Peritoneal MetastasesCONTESTNCT04744688
Changes in Coagulation in Colorectal Cancer Patients Undergoing Surgical Treatment
An observational study of Peritoneal Metastases and Peritoneal Carcinomatosis, run by University of Aarhus at 2 sites in Denmark.
Trial summary
Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) has prolonged the survival substantially for selected patients with peritoneal metastases from colorectal cancer.Bleeding and thromboembolic disease have been reported as postoperative complications related to this advanced open surgical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Metastases, Peritoneal Carcinomatosis, Colorectal Neoplasms Malignant
- How many people
- 90 participants
- Where
- 2 sitesDenmark
- Study dates
- 6 Apr 2021to 27 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include patients with peritoneal metastases from colorectal cancer undergoing cytoreductive surgery with HIPEC and rectal cancer patients undergoing minimally invasive rectal cancer resection. Patients will be identified at the outpatient clinic and undergo surgical treatment at the Department of Surgery, Aarhus University Hospital, Denmark.
Who may be able to join
- Cytoreductive surgery with HIPEC patients:
- Able to give informed consent
- Age ≥ 18 years
- Diagnosed with peritoneal metastases from colorectal cancer
- Planned to undergo cytoreductive surgery with HIPEC
- Minimally invasive rectal cancer patients:
Show all 10Show fewer
- Able to give informed consent
- Age ≥ 18 years
- Diagnosed with rectal cancer
- Planned to undergo minimal invasive rectal cancer resection with one of: total mesorectal excision, partial mesorectal excision or abdominoperineal excision
Who cannot join
- Thromboembolic event within 90 days before surgery
- Secondary malignancy within previous 5 years or concomitant, except non-melanoma skin cancer.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aarhus University Hospital
Aarhus, Aarhus N, 8200
Thrombosis and Haemostasis Research Unit, Department for Clinical Biochemistry, Aarhus University Hospital
Aarhus N, 8000
About this study
Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) has prolonged the survival substantially for selected patients with peritoneal metastases from colorectal cancer.Bleeding and thromboembolic disease have been reported as postoperative complications related to this advanced open surgical treatment. However, perioperative changes in coagulation and fibrinolysis are only sparsely reported in the literature.The mainstay of treatment with curative intend of none-advanced colorectal cancer is minimally invasive laparoscopic surgery followed by adjuvant chemotherapy. The approach is considered associated with a lower risk of thromboembolic disease than open surgery. Despite differences in extent of surgery and thromboembolic risk the same extended thromboprophylaxis regimen for 28 days is currently prescribed to patients undergoing cytoreductive surgery with HIPEC as well as minimally invasive rectal cancer resection. This study aims to investigate all parts of the coagulation system and fibrinolysis, and thereby thromboembolic risk and potential bleeding in two groups of patients with different extent of surgical trauma: 1) Colorectal cancer patients undergoing cytoreductive surgery with HIPEC and 2) rectal cancer patients undergoing minimal invasive rectal cancer resection. Our hypothesis is that patients undergoing cytoreductive surgery with HIPEC are exposed to more aggravated alterations of coagulation and fibrinolysis than patients undergoing minimally invasive rectal cancer resection.
- Conditions
- Peritoneal Metastases, Peritoneal Carcinomatosis, Colorectal Neoplasms Malignant, Intestinal Neoplasms, Cytoreductive Surgery, Venous Thromboembolism
- Keywords
- Bleeding, Venous thromboembolism, Coagulation, Cancer surgery, Thromboprophylaxis, Colorectal cancer, Cancer, Peritoneal metastases, Postoperative complications, Rectal cancer
- Medical subject headings
- Peritoneal Neoplasms, Colonic Neoplasms, Intestinal Neoplasms, Venous Thromboembolism, Hemorrhage, Thrombosis, Postoperative Complications, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 48 cytoreductive surgery with HIPEC patients | 48 patients with peritoneal metastases from colorectal cancer undergoing cytoreductive surgery with HIPEC (cytoreductive surgery with HIPEC patients) | |
| 48 minimally invasive patients | 48 rectal cancer patients undergoing minimally invasive rectal cancer resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between changes in concentration of prothrombin fragment 1+2.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Measured: Data will be analyzed, assessed, and presented within three years.
Secondary outcomes (42)
The difference between changes in platelet concentration from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Measured: Data will be analyzed, assessed, and presented within three years
The difference between changes in concentration of immature platelets from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Measured: Data will be analyzed, assessed, and presented within three years
The difference between changes in concentration of plasma selectin from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Measured: Data will be analyzed, assessed, and presented within three years
The difference between changes in activated partial thromboplastin time "APTT" (seconds) from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in international normalized ratio "INR" (seconds) from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of plasma fibrinogen from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of coagulation factor VIII from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of von wildebrand factor from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of thrombin-antithrombin complex from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in thrombin generation before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Thrombin generation will be measured by:
Lagtime (min), time to peak (min), peak thrombin (nM) and endogenous thrombin potential (nM*min).
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes of fibrin clot structure from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
The difference between changes of fibrin clot structure from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Fibrin clot structure will be measured by clot maximum, absorbance (arbitrary units), network density, lysis time (seconds), lysis area (balance between clot formation and lysis).
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of plasminogen activator inhibitor-1 from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of fibrin d-dimer from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in global hemostasis by Rotational thromboelastometry (ROTEM) from before surgery to the end of surgery (both groups)
The difference will be measured in blood samples from before surgery to the end of surgery (both groups).
ROTEM will include EXTEM, INTEM, FIBTEM, and APTEM by clotting time (seconds), clot formation time (seconds), alpha-angle (degrees), amplitude 10 min after clotting time (mm), maximum clot firmness (mm), lysis index 30 min after clotting time (mm), maximum lysis (mm).
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of syndecan-1 from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of sE-selectin from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of soluble thrombomodulin. from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of hemoglobin from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of leucocytes from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration C-reactive protein (CRP) from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery.
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of prothrombin fragment 1+2. from the end of cytoreductive surgery to the end of HIPEC.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end HIPEC.
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in platelet concentration from the end of cytoreductive surgery to the end HIPEC.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of immature platelets from the end of cytoreductive surgery to the end HIPEC.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in activated partial thromboplastin time "aPTT" (seconds) from the end of cytoreductive surgery to the end HIPEC.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in activated international normalized ratio "INR" (seconds) from the end of cytoreductive surgery to the end HIPEC.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of plasma fibrinogen from the end of cytoreductive surgery to the end HIPEC.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of coagulation factor VIII from the end of cytoreductive surgery to the end HIPEC.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of von wildebrand factor from the end of cytoreductive surgery to the end HIPEC.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of thrombin-antithrombin complex from the end of cytoreductive surgery to the end HIPEC.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in thrombin generation from the end of cytoreductive surgery to the end of HIPEC.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC. Thrombin generation will be measured by: Lagtime (min), time to peak (min), peak thrombin (nM) and endogenous thrombin potential (nM*min).
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes of fibrin clot structure from the end of cytoreductive surgery to the end of HIPEC.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC. Fibrin clot structure will be measured by clot maximum, absorbance (arbitrary units), network density, lysis time (seconds), lysis area (balance between clot formation and lysis).
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of plasminogen activator inhibitor-1 from the end of cytoreductive surgery to the end of HIPEC.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of fibrin d-dimer from the end of cytoreductive surgery to the end of HIPEC.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of global hemostasis measured by Rotational thromboelastometry (ROTEM) from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
The difference will be measured in blood samples from the end of cytoreductive surgery to the end HIPEC.
ROTEM will include EXTEM, INTEM, FIBTEM, and APTEM by clotting time (seconds), clot formation time (seconds), alpha-angle (degrees), amplitude 10 min after clotting time (mm), maximum clot firmness (mm), lysis index 30 min after clotting time (mm), maximum lysis (mm).
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of syndecan-1 from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end HIPEC.
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of sE-selectin from the end of cytoreductive surgery to the end of HIPEC
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of soluble thrombomodulin from the end of cytoreductive surgery to the end of HIPEC
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of hemoglobin from the end of cytoreductive surgery to the end of HIPEC.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of leucocytes from the end of cytoreductive surgery to the end of HIPEC.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Measured: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of C-reactive protein (CRP) from the end of cytoreductive surgery to the end of HIPEC.
The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Measured: Data will be analyzed, assessed, and presented within three years
Incidence of deep vein thrombosis measured by doppler ultrasonography in colorectal cancer patients undergoing minimally invasive rectal cancer resection.
Bilateral doppler ultrasonography of the veins in the lower extremities.The scan will be performed within the postoperative period from day 3 to day 7.
Measured: Data will be analyzed, assessed, and presented within three years
Incidence of deep venous thrombosis measured by doppler ultrasonography in colorectal cancer patients undergoing cytoreductive surgery with HIPEC
Bilateral doppler ultrasonography of the veins in the lower extremities.The scan will be performed within the postoperative period from day 3 to day 7.
Measured: Data will be analyzed, assessed, and presented within three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start6 Apr 2021
- Primary completion15 Dec 2023
- Study completion27 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal MetastasesStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Mette Hvas, MD, PhD, Principal investigator, Thrombosis and Haemostasis Research Unit, Department of Clinical Biochemistry, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744688
- Sponsor's protocol ID
- 1-10-72-212-20
- Acronym
- CONTEST
- Status last verified
- Dec 2020
- First submitted
- 4 Jan 2021
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Coagulation in Colorectal Cancer Patients Undergoing Surgical Treatment
- ClinicalTrials.gov ID
- NCT04744688
- Acronym / sponsor ID
- CONTEST / 1-10-72-212-20
- Conditions
- Peritoneal Metastases, Peritoneal Carcinomatosis, Colorectal Neoplasms Malignant, Intestinal Neoplasms, Cytoreductive Surgery, Venous Thromboembolism
- Keywords
- Bleeding, Venous thromboembolism, Coagulation, Cancer surgery, Thromboprophylaxis, Colorectal cancer, Cancer, Peritoneal metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 27 May 2024 (actual)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) has prolonged the survival substantially for selected patients with peritoneal metastases from colorectal cancer.Bleeding and thromboembolic disease have been reported as postoperative complications related to this advanced open surgical treatment. However, perioperative changes in coagulation and fibrinolysis are only sparsely reported in the literature.The mainstay of treatment with curative intend of none-advanced colorectal cancer is minimally invasive laparoscopic surgery followed by adjuvant chemotherapy. The approach is considered associated with a lower risk of thromboembolic disease than open surgery. Despite differences in extent of surgery and thromboembolic risk the same extended thromboprophylaxis regimen for 28 days is currently prescribed to patients undergoing cytoreductive surgery with HIPEC as well as minimally invasive rectal cancer resection. This study aims to investigate all parts of the coagulation system and fibrinolysis, and thereby thromboembolic risk and potential bleeding in two groups of patients with different extent of surgical trauma: 1) Colorectal cancer patients undergoing cytoreductive surgery with HIPEC and 2) rectal cancer patients undergoing minimal invasive rectal cancer resection. Our hypothesis is that patients undergoing cytoreductive surgery with HIPEC are exposed to more aggravated alterations of coagulation and fibrinolysis than patients undergoing minimally invasive rectal cancer resection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 48 cytoreductive surgery with HIPEC patients | – | –48 patients with peritoneal metastases from colorectal cancer undergoing cytoreductive surgery with HIPEC (cytoreductive surgery with HIPEC patients) |
| 48 minimally invasive patients | – | –48 rectal cancer patients undergoing minimally invasive rectal cancer resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include patients with peritoneal metastases from colorectal cancer undergoing cytoreductive surgery with HIPEC and rectal cancer patients undergoing minimally invasive rectal cancer resection. Patients will be identified at the outpatient clinic and undergo surgical treatment at the Department of Surgery, Aarhus University Hospital, Denmark.
Key inclusion criteria (10 listed)
- Able to give informed consent
- Age ≥ 18 years
- Diagnosed with peritoneal metastases from colorectal cancer
- Planned to undergo cytoreductive surgery with HIPEC
- Able to give informed consent
Key exclusion criteria (2 listed)
- Thromboembolic event within 90 days before surgery
- Secondary malignancy within previous 5 years or concomitant, except non-melanoma skin cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The difference between changes in concentration of prothrombin fragment 1+2.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
42 secondary outcomes
The difference between changes in platelet concentration from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time frame: Data will be analyzed, assessed, and presented within three years
The difference between changes in concentration of immature platelets from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time frame: Data will be analyzed, assessed, and presented within three years
The difference between changes in concentration of plasma selectin from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time frame: Data will be analyzed, assessed, and presented within three years
The difference between changes in activated partial thromboplastin time "APTT" (seconds) from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in international normalized ratio "INR" (seconds) from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of plasma fibrinogen from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of coagulation factor VIII from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of von wildebrand factor from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of thrombin-antithrombin complex from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in thrombin generation before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes of fibrin clot structure from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of plasminogen activator inhibitor-1 from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of fibrin d-dimer from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in global hemostasis by Rotational thromboelastometry (ROTEM) from before surgery to the end of surgery (both groups)
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of syndecan-1 from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of sE-selectin from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of soluble thrombomodulin. from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of hemoglobin from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of leucocytes from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration C-reactive protein (CRP) from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of prothrombin fragment 1+2. from the end of cytoreductive surgery to the end of HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in platelet concentration from the end of cytoreductive surgery to the end HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of immature platelets from the end of cytoreductive surgery to the end HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in activated partial thromboplastin time "aPTT" (seconds) from the end of cytoreductive surgery to the end HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in activated international normalized ratio "INR" (seconds) from the end of cytoreductive surgery to the end HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of plasma fibrinogen from the end of cytoreductive surgery to the end HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of coagulation factor VIII from the end of cytoreductive surgery to the end HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of von wildebrand factor from the end of cytoreductive surgery to the end HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of thrombin-antithrombin complex from the end of cytoreductive surgery to the end HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in thrombin generation from the end of cytoreductive surgery to the end of HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes of fibrin clot structure from the end of cytoreductive surgery to the end of HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of plasminogen activator inhibitor-1 from the end of cytoreductive surgery to the end of HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of fibrin d-dimer from the end of cytoreductive surgery to the end of HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of global hemostasis measured by Rotational thromboelastometry (ROTEM) from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of syndecan-1 from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of sE-selectin from the end of cytoreductive surgery to the end of HIPEC
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of soluble thrombomodulin from the end of cytoreductive surgery to the end of HIPEC
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of hemoglobin from the end of cytoreductive surgery to the end of HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of leucocytes from the end of cytoreductive surgery to the end of HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years.
The difference between changes in concentration of C-reactive protein (CRP) from the end of cytoreductive surgery to the end of HIPEC.
Time frame: Data will be analyzed, assessed, and presented within three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Mette Hvas, MD, PhD principal investigator
Thrombosis and Haemostasis Research Unit, Department of Clinical Biochemistry, Aarhus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritoneal Metastases and Peritoneal Carcinomatosis, run by University of Aarhus at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference between changes in concentration of prothrombin fragment 1+2. (time frame: Data will be analyzed, assessed, and presented within three years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.