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Completed

NCT Number: NCT06230640

Evaluation of TEG 6S PM® During Cardiopulmonary Bypass 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Département d'Anesthésie Réanimation cardio-thoracique - Hôpital Arnaud de Villeneuve - CHU Montpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

In vitro medical diagnostic device TEG6s® Platelet Mapping

Diagnostic Test

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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)

  7. 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Evaluation of TEG 6S Platelet Mapping® During Cardiopulmonary Bypass for Cardiac Surgery to Detect Postoperative Biological Coagulopathy

Acronym: PREDIPOC

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 30, 2024
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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