Head and Neck CancerMVL-COAGNCT04517461
Coagulation and Vitamin K in Head and Neck Microvascular Free Flap Surgery
An observational study of Head and Neck Cancer and Intraoperative Complications, run by Region Skane at 1 site in Sweden.
Trial summary
For patients with large head and neck tumors the recommended treatment, in many cases, is a combination of extensive surgery and postoperative radiotherapy. The surgical procedure involves resection of the tumor and reconstruction with a so called microvascular free flap, i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Intraoperative Complications, Coagulation Disorder, Blood
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 15 Sep 2020to 1 Oct 2021
- 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: All patients that present at, or are referred to, the Department of Otorhinolaryngology - Head and Neck Surgery at Skåne University Hospital in Lund with conditions requiring head and neck surgery including resection and reconstruction with a microvascular free flap. This includes patients from the entire southern health care region, "Södra sjukvårdsregionen".
Who may be able to join
- Patients undergoing head and neck surgery including resection and reconstruction with a microvascular free flap at Skåne University Hospital in Lund, Sweden, who accept participation in the study.
Who cannot join
- Age under 18 years.
- Inability to understand information or make an informed choice about participation.
- Hospitalization > 24 h prior to primary surgery.
Trial locations and contacts
1 site in 1 country.
About this study
For patients with large head and neck tumors the recommended treatment, in many cases, is a combination of extensive surgery and postoperative radiotherapy. The surgical procedure involves resection of the tumor and reconstruction with a so called microvascular free flap, i.e. tissue transferred from for instance the arm or leg to the resection site. Complications of this complex procedure include, but are not limited to, bleeding and blood cloths (thrombosis) in the transferred tissue (free flap), which can cause very serious complications including need for further surgery and loss of the flap.
Routine blood tests can measure parts of the system that regulates bleeding and the forming of blood clots, the so called coagulation system, but these tests don't cover the whole system. There are however more advanced instruments, such as ROTEM, rotational thromboelastometry, which provide a more global view of the hemostatic potential of whole blood. ROTEM is one of few more advanced assays that can be analyzed in emergency situations in major hospitals. Other more advanced coagulation assays are thrombin generation and measurements of specific coagulation factors, several of which are vitamin K dependent. Vitamin K is essential in the coagulation system and also involved in many other physiological processes. Deficiency of this vitamin is common, but not well studied in patients undergoing head an neck free flap surgery.
The investigators plan to study ROTEM and other above mentioned coagulation parameters in patients undergoing major head and neck surgery including microvascular free flap reconstruction to assess if these parameters can help predict patients at risk for bleeding or flap thrombosis. Further on this could hopefully enable prevention of complications and improve treatment of coagulation complications that still occur.
Read the detailed description
Microvascular reconstructive free flap surgery is an important part of the recommended treatment for extensive head and neck tumors. However, the procedure includes risks of perioperative coagulation related complications, such as bleeding, but also thrombosis in the flap blood vessels. In about 10% of cases this requires reoperation, but, in spite of intense efforts, about 5% of all patients suffer from flap failure, i.e. necrosis of the free flap. This results in significant suffering for the patients who must undergo further surgery and oftentimes considerable prolonged hospital stay etc. This in turn leads to increased health care costs. There are several indications that tendency towards thrombosis can increase the risk of flap failure.
Previous studies have indicated that increased levels of fibrinogen and inherited thrombophilia, such as APC resistance, are associated with thrombotic free flap complications, but more conventional coagulation parameters, such as PK/INR and aPTT have not shown the same connection. Low fibrinogen levels have also been associated with bleeding complications.
Most patients undergoing the above mentioned surgery receive anticoagulant therapy. However, there is no international consensus on any specific pharmacological regime. Many different prophylactic therapies are used, including low molecular weight heparin, dextran and acetylsalicylic acid. Still coagulation-related complications are difficult to prevent.
Defective coagulation apparently seems to be associated with bleeding and thrombotic perioperative complications. It would therefore be desirable to increase the knowledge about factors influencing the development of these complications, and the patients at risk for them. ROTEM, rotational thromboelastometry, is a viscoelastic essay that provides a more global view of the hemostatic potential in whole blood, and it is also one of few more advanced assays that can be analyzed around the clock in many Swedish hospitals.
The aim of this project is to study perioperative coagulation and vitamin K status, and thereby further on hopefully be able to prevent, and improve the treatment of, bleeding and thrombosis related complications in patients undergoing head and neck microvascular free flap surgery.
- Conditions
- Head and Neck Cancer, Intraoperative Complications, Coagulation Disorder, Blood, Vitamin K Deficiency, Thrombosis, Anticoagulants and Bleeding Disorders
- Medical subject headings
- Head and Neck Neoplasms, Intraoperative Complications, Blood Coagulation Disorders, Vitamin K Deficiency, Thrombosis, Hemostatic Disorders
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 |
|---|---|---|
| Head and neck free flap surgery patients | Patients undergoing head and neck microvascular free flap surgery at Skåne University Hospital, Lund, Sweden. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative changes in ROTEM MCF EXTEM
Perioperative changes in ROTEM MCF (EXTEM). Baseline values measured at start of surgery (day 0), thereafter repeated measurements are made until day 6. Power calculation is based on an expected change in ROTEM MCF (EXTEM) from day 0 to postoperative day 2 (based on Lison et al, Blood Coagul Fibrinolysis. 2011.).
Measured: Day 0 to day 6
Secondary outcomes (23)
Perioperative changes in ROTEM Clotting time
Perioperative changes in ROTEM Clotting Time (CT, s). Baseline values measured at start of surgery (day 0), thereafter repeated measurements are made until day 6.
Measured: Day 0 to day 6
Perioperative changes in ROTEM Clot Formation Time
Perioperative changes in ROTEM Clot Formation Time (CFT, s).
Measured: Day 0 to day 6
Perioperative changes in ROTEM alpha angle
Perioperative changes in ROTEM alpha angle (°).
Measured: Day 0 to day 6
Perioperative changes in ROTEM Lysis Index 60
Perioperative changes in ROTEM Lysis Index 60 (LI60, %).
Measured: Day 0 to day 6
Perioperative changes in ROTEM Maximum Clot Firmness
Perioperative changes in ROTEM Maximum Clot Firmness (mm).
Measured: Day 0 to day 6
Perioperative changes in prothrombin time
Perioperative changes in prothrombin time (INR).
Measured: Day 0 to day 6
Perioperative changes in activated partial thromboplastin time
Perioperative changes in activated partial thromboplastin time (APTT, s).
Measured: Day 0 to day 6
Perioperative changes in thrombocyte levels
Perioperative changes in thrombocyte levels (number/L).
Measured: Day 0 to day 6
Perioperative changes in thrombin generation; lag time
Perioperative changes in thrombin generation; lag time (s).
Measured: Day 0 to day 6
Perioperative changes in thrombin generation; peak thrombin
Perioperative changes in thrombin generation; peak thrombin (nM).
Measured: Day 0 to day 6
Perioperative changes in thrombin generation; area under the curve
Perioperative changes in thrombin generation; area under the curve (AUC).
Measured: Day 0 to day 6
Perioperative changes in specific coagulation factors; protein C (kIU/L)
Perioperative changes in protein C (kIU/L).
Measured: Day 0 to day 6
Perioperative changes in specific coagulation factors; protein S
Perioperative changes in protein S (kIU/L).
Measured: Day 0 to day 6
Perioperative changes in specific coagulation factors; fibrinogen
Perioperative changes in fibrinogen (g/L).
Measured: Day 0 to day 6
Perioperative changes in specific coagulation factors; antithrombin
Perioperative changes in antithrombin (kIU/L).
Measured: Day 0 to day 6
Perioperative changes in fibrinolytic activation
Perioperative changes in plasmin-antiplasmin complex, PAP (μg/L).
Measured: Day 0 to day 6
Perioperative changes in the vitamin K-dependent protein Gas6
Perioperative changes in the vitamin K-dependent protein Gas6 (ng/mL).
Measured: Day 0 to day 6
Perioperative changes in the vitamin K-dependent protein dp-uc-MGP
Perioperative changes in the vitamin K-dependent protein dp-uc-MGP (pM/L).
Measured: Day 0 to day 6
Perioperative changes in the vitamin K-dependent protein Axl-receptor
Perioperative changes in the vitamin K-dependent protein Axl-receptor (pg/mL).
Measured: Day 0 to day 6
Perioperative changes in the vitamin K-dependent protein PIVKA-II
Perioperative changes in the vitamin K-dependent protein PIVKA-II (mAU/mL).
Measured: Day 0 to day 6
Coagulation related complications
Connection between perioperative complications (thrombotic [arterial/venous] or bleeding) in the surgical site and abnormal levels of coagulation parameters mentioned above.
Measured: Day 0 until end of hospital stay or a at the latest day 30 days after the primary operation.
Perioperative changes in ROTEM FIBTEM Maximum Clot Firmness
Perioperative changes in ROTEM INTEM Maximum Clot Firmness (MCF, mm).
Measured: Day 0 to day 6
Perioperative changes in ROTEM INTEM Clotting Time
Perioperative changes in ROTEM INTEM Clotting Time (CT, s).
Measured: Day 0 to day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start15 Sep 2020
- Primary completion15 Sep 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline U Nilsson, MD, PhD, Study chair, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04517461
- Sponsor's protocol ID
- 2020-00718
- Acronym
- MVL-COAG
- Status last verified
- Apr 2022
- First submitted
- 3 Jul 2020
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cervenka B, Bewley AF. Free flap monitoring: a review of the recent literature. Curr Opin Otolaryngol Head Neck Surg. 2015 Oct;23(5):393-8. doi: 10.1097/MOO.0000000000000189.
PubMed 26339970Copelli C, Tewfik K, Cassano L, Pederneschi N, Catanzaro S, Manfuso A, Cocchi R. Management of free flap failure in head and neck surgery. Acta Otorhinolaryngol Ital. 2017 Oct;37(5):387-392. doi: 10.14639/0392-100X-1376.
PubMed 29165433Kolbenschlag J, Daigeler A, Lauer S, Wittenberg G, Fischer S, Kapalschinski N, Lehnhardt M, Goertz O. Can rotational thromboelastometry predict thrombotic complications in reconstructive microsurgery? Microsurgery. 2014 May;34(4):253-60. doi: 10.1002/micr.22199. Epub 2013 Oct 21.
PubMed 24142816Lison S, Weiss G, Spannagl M, Heindl B. Postoperative changes in procoagulant factors after major surgery. Blood Coagul Fibrinolysis. 2011 Apr;22(3):190-6. doi: 10.1097/MBC.0b013e328343f7be.
PubMed 21245747Handschel J, Burghardt S, Naujoks C, Kubler NR, Giers G. Parameters predicting complications in flap surgery. Oral Surg Oral Med Oral Pathol Oral Radiol. 2013 May;115(5):589-94. doi: 10.1016/j.oooo.2012.09.007. Epub 2012 Dec 12.
PubMed 23246227Kolbenschlag J, Diehm Y, Daigeler A, Kampa D, Fischer S, Kapalschinski N, Goertz O, Lehnhardt M. Insufficient fibrinogen response following free flap surgery is associated with bleeding complications. GMS Interdiscip Plast Reconstr Surg DGPW. 2016 Nov 22;5:Doc22. doi: 10.3205/iprs000101. eCollection 2016.
PubMed 27975041Zhou W, Zhang WB, Yu Y, Wang Y, Mao C, Guo CB, Yu GY, Peng X. Are antithrombotic agents necessary for head and neck microvascular surgery? Int J Oral Maxillofac Surg. 2019 Jul;48(7):869-874. doi: 10.1016/j.ijom.2018.10.022. Epub 2018 Nov 26.
PubMed 30497789
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coagulation and Vitamin K in Head and Neck Microvascular Free Flap Surgery
- ClinicalTrials.gov ID
- NCT04517461
- Acronym / sponsor ID
- MVL-COAG / 2020-00718
- Conditions
- Head and Neck Cancer, Intraoperative Complications, Coagulation Disorder, Blood, Vitamin K Deficiency, Thrombosis, Anticoagulants and Bleeding Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 18 Aug 2020 (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.
For patients with large head and neck tumors the recommended treatment, in many cases, is a combination of extensive surgery and postoperative radiotherapy. The surgical procedure involves resection of the tumor and reconstruction with a so called microvascular free flap, i.e. tissue transferred from for instance the arm or leg to the resection site. Complications of this complex procedure include, but are not limited to, bleeding and blood cloths (thrombosis) in the transferred tissue (free flap), which can cause very serious complications including need for further surgery and loss of the flap.
Routine blood tests can measure parts of the system that regulates bleeding and the forming of blood clots, the so called coagulation system, but these tests don't cover the whole system. There are however more advanced instruments, such as ROTEM, rotational thromboelastometry, which provide a more global view of the hemostatic potential of whole blood. ROTEM is one of few more advanced assays that can be analyzed in emergency situations in major hospitals. Other more advanced coagulation assays are thrombin generation and measurements of specific coagulation factors, several of which are vitamin K dependent. Vitamin K is essential in the coagulation system and also involved in many other physiological processes. Deficiency of this vitamin is common, but not well studied in patients undergoing head an neck free flap surgery.
The investigators plan to study ROTEM and other above mentioned coagulation parameters in patients undergoing major head and neck surgery including microvascular free flap reconstruction to assess if these parameters can help predict patients at risk for bleeding or flap thrombosis. Further on this could hopefully enable prevention of complications and improve treatment of coagulation complications that still occur.
Detailed description
Microvascular reconstructive free flap surgery is an important part of the recommended treatment for extensive head and neck tumors. However, the procedure includes risks of perioperative coagulation related complications, such as bleeding, but also thrombosis in the flap blood vessels. In about 10% of cases this requires reoperation, but, in spite of intense efforts, about 5% of all patients suffer from flap failure, i.e. necrosis of the free flap. This results in significant suffering for the patients who must undergo further surgery and oftentimes considerable prolonged hospital stay etc. This in turn leads to increased health care costs. There are several indications that tendency towards thrombosis can increase the risk of flap failure.
Previous studies have indicated that increased levels of fibrinogen and inherited thrombophilia, such as APC resistance, are associated with thrombotic free flap complications, but more conventional coagulation parameters, such as PK/INR and aPTT have not shown the same connection. Low fibrinogen levels have also been associated with bleeding complications.
Most patients undergoing the above mentioned surgery receive anticoagulant therapy. However, there is no international consensus on any specific pharmacological regime. Many different prophylactic therapies are used, including low molecular weight heparin, dextran and acetylsalicylic acid. Still coagulation-related complications are difficult to prevent.
Defective coagulation apparently seems to be associated with bleeding and thrombotic perioperative complications. It would therefore be desirable to increase the knowledge about factors influencing the development of these complications, and the patients at risk for them. ROTEM, rotational thromboelastometry, is a viscoelastic essay that provides a more global view of the hemostatic potential in whole blood, and it is also one of few more advanced assays that can be analyzed around the clock in many Swedish hospitals.
The aim of this project is to study perioperative coagulation and vitamin K status, and thereby further on hopefully be able to prevent, and improve the treatment of, bleeding and thrombosis related complications in patients undergoing head and neck microvascular free flap surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head and neck free flap surgery patients | – | –Patients undergoing head and neck microvascular free flap surgery at Skåne University Hospital, Lund, Sweden. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients that present at, or are referred to, the Department of Otorhinolaryngology - Head and Neck Surgery at Skåne University Hospital in Lund with conditions requiring head and neck surgery including resection and reconstruction with a microvascular free flap. This includes patients from the entire southern health care region, "Södra sjukvårdsregionen".
Key inclusion criteria (1 listed)
- Patients undergoing head and neck surgery including resection and reconstruction with a microvascular free flap at Skåne University Hospital in Lund, Sweden, who accept participation in the study.
Key exclusion criteria (3 listed)
- Age under 18 years.
- Inability to understand information or make an informed choice about participation.
- Hospitalization > 24 h prior to primary surgery.
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
Perioperative changes in ROTEM MCF EXTEM
Time frame: Day 0 to day 6
Perioperative changes in ROTEM MCF (EXTEM). Baseline values measured at start of surgery (day 0), thereafter repeated measurements are made until day 6. Power calculation is based on an expected change in ROTEM MCF (EXTEM) from day 0 to postoperative day 2 (based on Lison et al, Blood Coagul Fibrinolysis. 2011.).
23 secondary outcomes
Perioperative changes in ROTEM Clotting time
Time frame: Day 0 to day 6
Perioperative changes in ROTEM Clot Formation Time
Time frame: Day 0 to day 6
Perioperative changes in ROTEM alpha angle
Time frame: Day 0 to day 6
Perioperative changes in ROTEM Lysis Index 60
Time frame: Day 0 to day 6
Perioperative changes in ROTEM Maximum Clot Firmness
Time frame: Day 0 to day 6
Perioperative changes in prothrombin time
Time frame: Day 0 to day 6
Perioperative changes in activated partial thromboplastin time
Time frame: Day 0 to day 6
Perioperative changes in thrombocyte levels
Time frame: Day 0 to day 6
Perioperative changes in thrombin generation; lag time
Time frame: Day 0 to day 6
Perioperative changes in thrombin generation; peak thrombin
Time frame: Day 0 to day 6
Perioperative changes in thrombin generation; area under the curve
Time frame: Day 0 to day 6
Perioperative changes in specific coagulation factors; protein C (kIU/L)
Time frame: Day 0 to day 6
Perioperative changes in specific coagulation factors; protein S
Time frame: Day 0 to day 6
Perioperative changes in specific coagulation factors; fibrinogen
Time frame: Day 0 to day 6
Perioperative changes in specific coagulation factors; antithrombin
Time frame: Day 0 to day 6
Perioperative changes in fibrinolytic activation
Time frame: Day 0 to day 6
Perioperative changes in the vitamin K-dependent protein Gas6
Time frame: Day 0 to day 6
Perioperative changes in the vitamin K-dependent protein dp-uc-MGP
Time frame: Day 0 to day 6
Perioperative changes in the vitamin K-dependent protein Axl-receptor
Time frame: Day 0 to day 6
Perioperative changes in the vitamin K-dependent protein PIVKA-II
Time frame: Day 0 to day 6
Coagulation related complications
Time frame: Day 0 until end of hospital stay or a at the latest day 30 days after the primary operation.
Perioperative changes in ROTEM FIBTEM Maximum Clot Firmness
Time frame: Day 0 to day 6
Perioperative changes in ROTEM INTEM Clotting Time
Time frame: Day 0 to day 6
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 Feb 2024.
- Background: PubMed 26339970Cervenka B, Bewley AF. Free flap monitoring: a review of the recent literature. Curr Opin Otolaryngol Head Neck Surg. 2015 Oct;23(5):393-8. doi: 10.1097/MOO.0000000000000189.
- Background: PubMed 29165433Copelli C, Tewfik K, Cassano L, Pederneschi N, Catanzaro S, Manfuso A, Cocchi R. Management of free flap failure in head and neck surgery. Acta Otorhinolaryngol Ital. 2017 Oct;37(5):387-392. doi: 10.14639/0392-100X-1376.
- Background: PubMed 24142816Kolbenschlag J, Daigeler A, Lauer S, Wittenberg G, Fischer S, Kapalschinski N, Lehnhardt M, Goertz O. Can rotational thromboelastometry predict thrombotic complications in reconstructive microsurgery? Microsurgery. 2014 May;34(4):253-60. doi: 10.1002/micr.22199. Epub 2013 Oct 21.
- Background: PubMed 21245747Lison S, Weiss G, Spannagl M, Heindl B. Postoperative changes in procoagulant factors after major surgery. Blood Coagul Fibrinolysis. 2011 Apr;22(3):190-6. doi: 10.1097/MBC.0b013e328343f7be.
- Background: PubMed 23246227Handschel J, Burghardt S, Naujoks C, Kubler NR, Giers G. Parameters predicting complications in flap surgery. Oral Surg Oral Med Oral Pathol Oral Radiol. 2013 May;115(5):589-94. doi: 10.1016/j.oooo.2012.09.007. Epub 2012 Dec 12.
- Background: PubMed 27975041Kolbenschlag J, Diehm Y, Daigeler A, Kampa D, Fischer S, Kapalschinski N, Goertz O, Lehnhardt M. Insufficient fibrinogen response following free flap surgery is associated with bleeding complications. GMS Interdiscip Plast Reconstr Surg DGPW. 2016 Nov 22;5:Doc22. doi: 10.3205/iprs000101. eCollection 2016.
- Background: PubMed 30497789Zhou W, Zhang WB, Yu Y, Wang Y, Mao C, Guo CB, Yu GY, Peng X. Are antithrombotic agents necessary for head and neck microvascular surgery? Int J Oral Maxillofac Surg. 2019 Jul;48(7):869-874. doi: 10.1016/j.ijom.2018.10.022. Epub 2018 Nov 26.
- Individual participant dataSharing planned: No
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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.
Caroline U Nilsson, MD, PhD study chair
Skane University Hospital
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 Head and Neck Cancer and Intraoperative Complications, run by Region Skane at 1 site in Sweden.
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 1 inclusion and 3 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 Feb 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 Sweden. 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?
Perioperative changes in ROTEM MCF EXTEM (time frame: Day 0 to day 6). 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 NCT04517461, which also lists 7 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 29 Feb 2024.