Coagulation DisorderNCT05824013
Blood Coagulation Profile After Liver Resection.
An observational study of Coagulation Disorder, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Liver resection is the treatment of choice in patients with primary or metastatic liver neoplasms, benign liver neoplasms and numerous biliary diseases. In these patients, in the postoperative period,several factors can induce a transient alteration of the synthesis hepatic coagulation factors such as size of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coagulation Disorder
- What is being tested?
- thromboelastography (TEG®6s)
- How many people
- 46 participants
- Where
- 1 siteItaly
- Study dates
- 12 Apr 2023to 31 Oct 2023
- 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: Adult patients undergoing liver surgery resective for primary or secondary neoplastic disease admitted to surgical intensive care unit at the end of surgery
Who may be able to join
- Elective liver resection surgery for liver cancer primary or metastatic
- Admission to surgical intensive care unit at the end of the surgery.
Who cannot join
- Renal disease (creatinine clearance < 30 ml/min)
- pregnancy
- Benign liver disease
- Emergency surgery
- Reintervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood Caogulation Profile After Liver Resection. Comparison of Conventional Blood Coagulation Tests With Thromboelastography
Liver resection is the treatment of choice in patients with primary or metastatic liver neoplasms, benign liver neoplasms and numerous biliary diseases. In these patients, in the postoperative period,several factors can induce a transient alteration of the synthesis hepatic coagulation factors such as size of the lesion liver, underlying liver disease (e.g. malignancy), pre-existing cirrhosis, duration of both surgery and vascular clamping, and blood loss. So far, some studies have shown that conventional coagulation tests indicate a hypocoagulable state which may lead to excessive transfusions of blood products or an increased risk of thromboembolic events related to delayed initiation of thromboprophylaxis in the postoperative period. In an attempt to optimizing the state of coagulation, recently there is increased interest for viscoelastic coagulation testing (thromboelastography and rotational thromboelastometry). The results of these studies have shown that these patients often have a hypercoagulable and non hypocoagulable profile as evidenced by conventional coagulation tests.
the purpose of the study is to evaluate whether the combination of coagulation tests conventional systems and new thromboelastography can increase the quality of surveillance of the coagulation state after liver surgery, in order to optimize the management of postoperative blood coagulation of these patients.
- Conditions
- Coagulation Disorder
- Being tested
- thromboelastography (TEG®6s)
- Medical subject headings
- Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thromboelastography (TEG®6s)Diagnostic test
blood samples for conventional coagulation test were obtained in vacutainer tubes from an arterial line. Two blood citrate samples (3 ml, sodium citrate solution, Vacuette® Blood Tubes) were also collected for the laboratory conventional coagulation tests (aPTT, INR, D-dimer levels, Antithrombin III) and TEG®6s assessment. The TEG parameters include reaction time (R), clot formation time (K), angle or α (K angle), maximum amplitude (MA), and amplitude at 30 minutes (LY30)
What is being measured
The primary outcome is the main question the study is designed to answer.
blood coagulation profile
Evaluate whether to use TEG®6s, in addition to coagulation tests conventional, optimizes the postoperative hemocoagulation management of patients undergoing resective liver surgery in terms of consumption transfusion of plasma and blood products.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start12 Apr 2023
- Primary completion31 Jul 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coagulation DisorderStudies of the same condition, open and under way.
- 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824013
- Sponsor's protocol ID
- 5492
- Status last verified
- Apr 2023
- First submitted
- 11 Apr 2023
- Last updated
- 25 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ardito F, Vellone M, Barbaro B, Grande G, Clemente G, Giovannini I, Federico B, Bonomo L, Nuzzo G, Giuliante F. Right and extended-right hepatectomies for unilobar colorectal metastases: impact of portal vein embolization on long-term outcome and liver recurrence. Surgery. 2013 Jun;153(6):801-10. doi: 10.1016/j.surg.2013.02.001.
PubMed 23701876Dumitrescu G, Januszkiewicz A, Agren A, Magnusson M, Isaksson B, Wernerman J. The temporal pattern of postoperative coagulation status in patients undergoing major liver surgery. Thromb Res. 2015 Aug;136(2):402-7. doi: 10.1016/j.thromres.2015.05.023. Epub 2015 May 24.
PubMed 26048400Blasi A, Molina V, Sanchez-Cabus S, Balust J, Garcia-Valdecasas JC, Taura P. Prediction of thromboembolic complications after liver resection for cholangiocarcinoma: is there a place for thromboelastometry? Blood Coagul Fibrinolysis. 2018 Jan;29(1):61-66. doi: 10.1097/MBC.0000000000000672.
PubMed 29045240
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Caogulation Profile After Liver Resection. Comparison of Conventional Blood Coagulation Tests With Thromboelastography
- ClinicalTrials.gov ID
- NCT05824013
- Acronym / sponsor ID
- 5492
- Conditions
- Coagulation Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 21 Apr 2023 (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.
Liver resection is the treatment of choice in patients with primary or metastatic liver neoplasms, benign liver neoplasms and numerous biliary diseases. In these patients, in the postoperative period,several factors can induce a transient alteration of the synthesis hepatic coagulation factors such as size of the lesion liver, underlying liver disease (e.g. malignancy), pre-existing cirrhosis, duration of both surgery and vascular clamping, and blood loss. So far, some studies have shown that conventional coagulation tests indicate a hypocoagulable state which may lead to excessive transfusions of blood products or an increased risk of thromboembolic events related to delayed initiation of thromboprophylaxis in the postoperative period. In an attempt to optimizing the state of coagulation, recently there is increased interest for viscoelastic coagulation testing (thromboelastography and rotational thromboelastometry). The results of these studies have shown that these patients often have a hypercoagulable and non hypocoagulable profile as evidenced by conventional coagulation tests.
the purpose of the study is to evaluate whether the combination of coagulation tests conventional systems and new thromboelastography can increase the quality of surveillance of the coagulation state after liver surgery, in order to optimize the management of postoperative blood coagulation of these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing liver surgery resective for primary or secondary neoplastic disease admitted to surgical intensive care unit at the end of surgery
Key inclusion criteria (2 listed)
- Elective liver resection surgery for liver cancer primary or metastatic
- Admission to surgical intensive care unit at the end of the surgery.
Key exclusion criteria (5 listed)
- Renal disease (creatinine clearance < 30 ml/min)
- pregnancy
- Benign liver disease
- Emergency surgery
- Reintervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thromboelastography (TEG®6s)blood samples for conventional coagulation test were obtained in vacutainer tubes from an arterial line. Two blood citrate samples (3 ml, sodium citrate solution, Vacuette® Blood Tubes) were also collected for the laboratory conventional coagulation tests (aPTT, INR, D-dimer levels, Antithrombin III) and TEG®6s assessment. The TEG parameters include reaction time (R), clot formation time (K), angle or α (K angle), maximum amplitude (MA), and amplitude at 30 minutes (LY30) | Diagnostic test | – |
Primary outcome
blood coagulation profile
Time frame: 12 hours
Evaluate whether to use TEG®6s, in addition to coagulation tests conventional, optimizes the postoperative hemocoagulation management of patients undergoing resective liver surgery in terms of consumption transfusion of plasma and blood products.
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 25 Jan 2024.
- Results publication: PubMed 23701876Ardito F, Vellone M, Barbaro B, Grande G, Clemente G, Giovannini I, Federico B, Bonomo L, Nuzzo G, Giuliante F. Right and extended-right hepatectomies for unilobar colorectal metastases: impact of portal vein embolization on long-term outcome and liver recurrence. Surgery. 2013 Jun;153(6):801-10. doi: 10.1016/j.surg.2013.02.001.
- Results publication: PubMed 26048400Dumitrescu G, Januszkiewicz A, Agren A, Magnusson M, Isaksson B, Wernerman J. The temporal pattern of postoperative coagulation status in patients undergoing major liver surgery. Thromb Res. 2015 Aug;136(2):402-7. doi: 10.1016/j.thromres.2015.05.023. Epub 2015 May 24.
- Results publication: PubMed 29045240Blasi A, Molina V, Sanchez-Cabus S, Balust J, Garcia-Valdecasas JC, Taura P. Prediction of thromboembolic complications after liver resection for cholangiocarcinoma: is there a place for thromboelastometry? Blood Coagul Fibrinolysis. 2018 Jan;29(1):61-66. doi: 10.1097/MBC.0000000000000672.
Related trials for Coagulation Disorder
RecruitingPhase 1/2
Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT)
Hereditary Hemorrhagic Telangiectasia (HHT), Osler Weber Rendu Disease
Recruiting
Functional and Phenotypic Characterization of Monocytes in Myeloproliferative Syndromes
Myeloproliferative Neoplasm, Polycythemia Vera
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
Not yet recruitingPhase 1
Phase 1 Dose Escalation Study of RXIM002 in Autoimmune Cytopenias
Immune Thrombocytopenia (ITP)
RecruitingObservational study
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
Chronic Myeloproliferative Disorders, Leukemia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coagulation Disorder, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 2 inclusion and 5 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 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
blood coagulation profile (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05824013, which also lists 3 linked publications.
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 25 Jan 2024.