CoagulopathyPREDIPOCNCT06230640
Evaluation of TEG 6S PM® During Cardiopulmonary Bypass to Detect Postoperative Biological Coagulopathy
An observational study of Coagulopathy and Cardiopulmonary Bypass, run by University Hospital, Montpellier at 1 site in France.
Trial summary
This is a prospective study to evaluate the predictive value of the TEG 6s platelet mapping® (TEG 6s® PM) performed during cardiopulmonary bypass (CPB) in the prediction of biological coagulopathy (determined by TEG 6S global hemostasis®), in cardiac surgery with high risk of bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coagulopathy, Cardiopulmonary Bypass, Cardiac Surgery
- What is being tested?
- In vitro medical diagnostic device TEG6s® Platelet Mapping
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2024to 10 Mar 2025
- 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: Any subject undergoing cardiac surgery with cardiopulmonary bypass circulation and at high risk of bleeding and transfusion.
Who may be able to join
- 18 years old or older
- Cardiac surgery under cardiopulmonary bypass with high risk of bleeding defined among:
- CPB with circulatory arrest
- cardiac transplantation
- Redo surgery
- infective endocarditis
- predicted duration of CBP ≥ 120 min
- High transfusion risk defined by a Trust predictive score ≥ 3 (Transfusion Risk Understanding Scoring Tool)
Who cannot join
- Patient with heparin allergy or heparin-induced thrombocytopenia
- Use of direct oral anticoagulant (DAA) with anti-factor X activity (Apixaban, Rivaroxaban) < 72h, even if antagonized
- Patient on partially or fully antagonized VKAs
- Opposition to participation after a period of reflection
- Adult protected by law (guardianship, curatorship)
- Person deprived of liberty
Show all 9Show fewer
- Person participating in another study with an exclusion period still in progress
- Patient not affiliated to a social security scheme or not benefiting from such a scheme
- Pregnant or breast-feeding woman
Trial locations and contacts
1 site in 1 country.
France1 site
Département d'Anesthésie Réanimation cardio-thoracique - Hôpital Arnaud de Villeneuve - CHU Montpellier
Montpellier, 34295
About this study
Official title: Evaluation of TEG 6S Platelet Mapping® During Cardiopulmonary Bypass for Cardiac Surgery to Detect Postoperative Biological Coagulopathy
This is a prospective study to evaluate the predictive value of the TEG 6s platelet mapping® (TEG 6s® PM) performed during cardiopulmonary bypass (CPB) in the prediction of biological coagulopathy (determined by TEG 6S global hemostasis®), in cardiac surgery with high risk of bleeding.
Read the detailed description
The aim of this prospective study is to evaluate the predictive value of the R time (HKH) given by the TEG 6s platelet mapping® performed during the CPB in the prediction of postoperative biological coagulopathy.
In order to evaluate its interest and to validate its use during cardiac surgery with high bleeding risk under CPB, we plan to compare 2 thromboelastographic tests in the detection of biological coagulopathy: TEG 6S citrated® (reference) and TEG 6S platelet mapping®. Biological coagulopathy is defined by a kaolin-heparinase assay coagulation/reaction time (CKH R) value of 7 min on TEG 6S citrated® (fibrinogen impairment defined by a Comparison of functional fibrinogen Maximal Amplitude (CFF MA) < 20 mm, and CKH MA impairment (< 60 mm), in accordance with established laboratory standard values.
- Conditions
- Coagulopathy, Cardiopulmonary Bypass, Cardiac Surgery
- Being tested
- In vitro medical diagnostic device TEG6s® Platelet Mapping
- Keywords
- Coagulopathy, cardiac surgery, cardiopulmonary bypass
- Medical subject headings
- Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In vitro medical diagnostic device TEG6s® Platelet MappingDiagnostic test
Also called Comparison between TEG 6S platelet mapping® and TEG 6S global hemostasis Assessment of platelet inhibition rate
Preoperative period:
- Pre-operative blood sampling, according to the usual practices of the unit before surgery
- Collection of the patient's usual demographic characteristics per operative period :
- After anesthetic induction:a TEG6S platelet mapping® sampled from the arterial catheter routinely placed after anesthetic induction
- During the CPB, 30 min before aortic declamping: performing TEG 6S platelet mapping® (heparinized tube)
- 5 min after heparin antagonization by protamine, after the weaning of the bypass, and before any transfusion: performing a TEG 6S citrate® (citrated tube)
Post-operative period (resuscitation):
- postoperative bleeding at 2 hours and during the first 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| cardiac surgery with cardiopulmonary bypass | Any subject undergoing cardiac surgery with cardiopulmonary bypass and at high risk of bleeding and transfusion. Receives: Diagnostic Test: In vitro medical diagnostic device TEG6s® Platelet Mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolongation of the R in kaolin with heparinase (HKH) of TEG 6S platelet mapping® during cardiopulmonary bypass.
The measurement of the R time (coagulation time in minutes) is automated by using a TEG 6S® analyzer from the Haemonetics laboratory and using the TEG 6S platelet mapping® and global hemostasis® cartridge.
Measured: After anesthetic induction; 30 min before aortic declamping and 5min after antagonization
Secondary outcomes (7)
Change in maximum amplitude HKH (MA HKH) of TEG 6S platelet mapping® during CPB.
The measurement of the various parameters (coagulation time R in minutes, maximum amplitude of the clot strength MA in millimeter mm) is automated by using a TEG 6S® analyzer from the Haemonetics laboratory, which is already available in our unit, and using the TEG 6S platelet mapping® and citrated® cartridge.
Measured: After anesthetic induction; 30 min before aortic declamping
Change in maximum amplitude in the presence of fibrinogen activator (MA ActF) of TEG 6S platelet mapping® during CPB.
The measurement of the various parameters (coagulation time R in minutes, maximum amplitude of the clot strength MA in millimeter mm) is automated by using a TEG 6S® analyzer from the Haemonetics laboratory, which is already available in our unit, and using the TEG 6S platelet mapping® and citrated® cartridge.
Measured: After anesthetic induction; 30 min before aortic declamping
Maximum amplitude change in the presence of arachidonic acid (MA AA) in TEG 6S platelet mapping® during CPB.
The measurement of the various parameters (coagulation time R in minutes, maximum amplitude of the clot strength MA in millimeter mm) is automated by using a TEG 6S® analyzer from the Haemonetics laboratory, which is already available in our unit, and using the TEG 6S platelet mapping® and citrated® cartridge.
Measured: After anesthetic induction; 30 min before aortic declamping
Maximum amplitude change in the presence of P2Y12 receptor activating ADP (MA ADP) of TEG 6S platelet mapping® during CPB.
The measurement of the various parameters (coagulation time R in minutes, maximum amplitude of the clot strength MA in millimeter mm) is automated by using a TEG 6S® analyzer from the Haemonetics laboratory, which is already available in our unit, and using the TEG 6S platelet mapping® and citrated® cartridge.
Measured: After anesthetic induction; 30 min before aortic declamping
Correlation between the R HKH time of TEG 6S platelet mapping® and the R CKH of TEG 6S citrated®.
The measurement of the various parameters (coagulation time R in minutes, maximum amplitude of the clot strength MA in millimeter mm) is automated by using a TEG 6S® analyzer from the Haemonetics laboratory, which is already available in our unit, and using the TEG 6S platelet mapping® and citrated® cartridge.
Measured: After anesthetic induction; 30 min before aortic declamping and 5min after antagonization
Post-operative bleeding over the first 2 hours
Volume measured by drains connected to graduated sterile jars. Blood volume in milliliters (mL)
Measured: during the 2 hours post-surgery
Post-operative bleeding over 12 hours in intensive care
Volume measured by drains connected to graduated sterile jars. Blood volume in milliliters (mL)
Measured: during the 12 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Jul 2024
- Primary completion10 Mar 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CoagulopathyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Bourdois, MD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230640
- Sponsor's protocol ID
- RECHMPL23_0167
- Acronym
- PREDIPOC
- Status last verified
- Mar 2025
- First submitted
- 19 Jan 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yamamoto Y, Sato Y, Takahashi M, Yamamoto H, Echizen M, Uchida T. TEG6s Platelet Mapping assay for the estimation of plasma fibrinogen concentration during cardiovascular surgery: a single-center prospective observational study. J Anesth. 2022 Feb;36(1):79-88. doi: 10.1007/s00540-021-03009-4. Epub 2021 Oct 13.
PubMed 34643817
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of TEG 6S Platelet Mapping® During Cardiopulmonary Bypass for Cardiac Surgery to Detect Postoperative Biological Coagulopathy
- ClinicalTrials.gov ID
- NCT06230640
- Acronym / sponsor ID
- PREDIPOC / RECHMPL23_0167
- Conditions
- Coagulopathy, Cardiopulmonary Bypass, Cardiac Surgery
- Keywords
- Coagulopathy, cardiac surgery, cardiopulmonary bypass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 30 Jan 2024 (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.
This is a prospective study to evaluate the predictive value of the TEG 6s platelet mapping® (TEG 6s® PM) performed during cardiopulmonary bypass (CPB) in the prediction of biological coagulopathy (determined by TEG 6S global hemostasis®), in cardiac surgery with high risk of bleeding.
Detailed description
The aim of this prospective study is to evaluate the predictive value of the R time (HKH) given by the TEG 6s platelet mapping® performed during the CPB in the prediction of postoperative biological coagulopathy.
In order to evaluate its interest and to validate its use during cardiac surgery with high bleeding risk under CPB, we plan to compare 2 thromboelastographic tests in the detection of biological coagulopathy: TEG 6S citrated® (reference) and TEG 6S platelet mapping®. Biological coagulopathy is defined by a kaolin-heparinase assay coagulation/reaction time (CKH R) value of 7 min on TEG 6S citrated® (fibrinogen impairment defined by a Comparison of functional fibrinogen Maximal Amplitude (CFF MA) < 20 mm, and CKH MA impairment (< 60 mm), in accordance with established laboratory standard values.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cardiac surgery with cardiopulmonary bypass | – | Diagnostic Test: In vitro medical diagnostic device TEG6s® Platelet MappingAny subject undergoing cardiac surgery with cardiopulmonary bypass and at high risk of bleeding and transfusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any subject undergoing cardiac surgery with cardiopulmonary bypass circulation and at high risk of bleeding and transfusion.
Key inclusion criteria (8 listed)
- 18 years old or older
- Cardiac surgery under cardiopulmonary bypass with high risk of bleeding defined among:
- CPB with circulatory arrest
- cardiac transplantation
- Redo surgery
Key exclusion criteria (9 listed)
- Patient with heparin allergy or heparin-induced thrombocytopenia
- Use of direct oral anticoagulant (DAA) with anti-factor X activity (Apixaban, Rivaroxaban) < 72h, even if antagonized
- Patient on partially or fully antagonized VKAs
- Opposition to participation after a period of reflection
- Adult protected by law (guardianship, curatorship)
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 |
|---|---|---|
| In vitro medical diagnostic device TEG6s® Platelet MappingAlso: Comparison between TEG 6S platelet mapping® and TEG 6S global hemostasis Assessment of platelet inhibition ratePreoperative period: * Pre-operative blood sampling, according to the usual practices of the unit before surgery * Collection of the patient's usual demographic characteristics per operative period : * After anesthetic induction:a TEG6S platelet mapping® sampled from the arterial catheter routinely placed after anesthetic induction * During the CPB, 30 min before aortic declamping: performing TEG 6S platelet mapping® (heparinized tube) * 5 min after heparin antagonization by protamine, after the weaning of the bypass, and before any transfusion: performing a TEG 6S citrate® (citrated tube) Post-operative period (resuscitation): • postoperative bleeding at 2 hours and during the first 12 hours. | Diagnostic test | cardiac surgery with cardiopulmonary bypass |
Primary outcome
Prolongation of the R in kaolin with heparinase (HKH) of TEG 6S platelet mapping® during cardiopulmonary bypass.
Time frame: After anesthetic induction; 30 min before aortic declamping and 5min after antagonization
The measurement of the R time (coagulation time in minutes) is automated by using a TEG 6S® analyzer from the Haemonetics laboratory and using the TEG 6S platelet mapping® and global hemostasis® cartridge.
7 secondary outcomes
Change in maximum amplitude HKH (MA HKH) of TEG 6S platelet mapping® during CPB.
Time frame: After anesthetic induction; 30 min before aortic declamping
Change in maximum amplitude in the presence of fibrinogen activator (MA ActF) of TEG 6S platelet mapping® during CPB.
Time frame: After anesthetic induction; 30 min before aortic declamping
Maximum amplitude change in the presence of arachidonic acid (MA AA) in TEG 6S platelet mapping® during CPB.
Time frame: After anesthetic induction; 30 min before aortic declamping
Maximum amplitude change in the presence of P2Y12 receptor activating ADP (MA ADP) of TEG 6S platelet mapping® during CPB.
Time frame: After anesthetic induction; 30 min before aortic declamping
Correlation between the R HKH time of TEG 6S platelet mapping® and the R CKH of TEG 6S citrated®.
Time frame: After anesthetic induction; 30 min before aortic declamping and 5min after antagonization
Post-operative bleeding over the first 2 hours
Time frame: during the 2 hours post-surgery
Post-operative bleeding over 12 hours in intensive care
Time frame: during the 12 hours post-surgery
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 12 Mar 2025.
- Results publication: PubMed 34643817Yamamoto Y, Sato Y, Takahashi M, Yamamoto H, Echizen M, Uchida T. TEG6s Platelet Mapping assay for the estimation of plasma fibrinogen concentration during cardiovascular surgery: a single-center prospective observational study. J Anesth. 2022 Feb;36(1):79-88. doi: 10.1007/s00540-021-03009-4. Epub 2021 Oct 13.
- 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.
Benjamin Bourdois, MD study director
University Hospital, Montpellier
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 Coagulopathy and Cardiopulmonary Bypass, run by University Hospital, Montpellier at 1 site in France.
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 8 inclusion and 9 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 12 Mar 2025. 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 France. 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?
Prolongation of the R in kaolin with heparinase (HKH) of TEG 6S platelet mapping® during cardiopulmonary bypass. (time frame: After anesthetic induction; 30 min before aortic declamping and 5min after antagonization). 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 NCT06230640, which also lists 1 linked publication.
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 12 Mar 2025.