Evaluation of TEG 6S PM® During Cardiopulmonary Bypass to Detect Postoperative Biological Coagulopathy (PREDIPOC)

March 11, 2025 updated by: University Hospital, Montpellier

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Montpellier, France, 34295
        • Département d'Anesthésie Réanimation cardio-thoracique - Hôpital Arnaud de Villeneuve - CHU Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Any subject undergoing cardiac surgery with cardiopulmonary bypass circulation and at high risk of bleeding and transfusion.

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
cardiac surgery with cardiopulmonary bypass
Any subject undergoing cardiac surgery with cardiopulmonary bypass and at high risk of bleeding and transfusion.
Diagnostic test: In vitro medical diagnostic device TEG6s® Platelet Mapping

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.

Other Names:
  • Comparison between TEG 6S platelet mapping® and TEG 6S global hemostasis Assessment of platelet inhibition rate

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
After anesthetic induction; 30 min before aortic declamping and 5min after antagonization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in maximum amplitude HKH (MA HKH) of TEG 6S platelet mapping® during CPB.
Time Frame: After anesthetic induction; 30 min before aortic declamping
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.
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
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.
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
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.
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
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.
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
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.
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
Volume measured by drains connected to graduated sterile jars. Blood volume in milliliters (mL)
during the 2 hours post-surgery
Post-operative bleeding over 12 hours in intensive care
Time Frame: during the 12 hours post-surgery
Volume measured by drains connected to graduated sterile jars. Blood volume in milliliters (mL)
during the 12 hours post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Benjamin Bourdois, MD, University Hospital, Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 10, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RECHMPL23_0167

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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