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

Last updated: March 11, 2025
Sponsor: University Hospital, Montpellier
Overall Status: Completed

Phase

N/A

Condition

Cardiac Surgery

Blood Clots

Treatment

In vitro medical diagnostic device TEG6s® Platelet Mapping

Clinical Study ID

NCT06230640
RECHMPL23_0167
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years old or older

  • Cardiac surgery under cardiopulmonary bypass with high risk of bleeding definedamong:

  • 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 RiskUnderstanding Scoring Tool)

Exclusion

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 ascheme

  • Pregnant or breast-feeding woman

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: In vitro medical diagnostic device TEG6s® Platelet Mapping
Phase:
Study Start date:
July 01, 2024
Estimated Completion Date:
March 10, 2025

Study 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.

Connect with a study center

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

    Montpellier, 34295
    France

    Site Not Available

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