TEG 6s® for Perioperative Monitoring of Platelet Function During Cardiopulmonary Bypass for Cardiac Surgery

NCT ID: NCT04746560

Last Updated: 2022-01-31

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 6 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-21
• Study Completion Date: 2021-05-07

Brief Summary

Excessive bleeding is common during cardiopulmonary bypass (CPB) for cardiac surgery. This may result from the systemic activation of the coagulation pathway and the acquired platelet dysfunction during the procedure. This study aims to compare the diagnostic performances of the TEG®6S device and its Platelet mapping® cartridge to those of the "gold standard" tests (light transmittance aggregometry and Multiplate®) for platelet function monitoring in patients undergoing CPB for cardiac surgery.

Detailed Description

Excessive bleeding is common during cardiopulmonary bypass (CPB) for cardiac surgery. This may result from the systemic activation of the coagulation pathway and the acquired platelet dysfunction during the procedure. This study aims to compare the diagnostic performances of the TEG®6S device and its Platelet mapping® cartridge to those of the "gold standard" tests (light transmittance aggregometry and Multiplate®) for platelet function monitoring in patients undergoing CPB for cardiac surgery.

Conditions

Cardiopulmonary Bypass

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

TEG®6S device with its Platelet mapping® cartridge

Platelet function monitoring using the TEG®6S device with its Platelet mapping® cartridge

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients scheduled to undergo cardiopulmonary bypass
• Informed consent

Exclusion Criteria

• Age <18 years
• Pregnant women
• Emergency surgery
• Cardiac surgery without CPB
• thrombocytopenia <100000/mmm3

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adrien BOUGLE, MD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Ahmed ABBES, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Département d'Anesthésie-Réanimation,Hopital Pitié Salpêtrière

Paris, , France

Countries

France

Other Identifiers

APHP201216

Identifier Type: -

Identifier Source: org_study_id