NCT04746560

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

April 21, 2021

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2021

Completed
Last Updated

January 31, 2022

Status Verified

September 1, 2021

Enrollment Period

16 days

First QC Date

December 11, 2020

Last Update Submit

January 28, 2022

Conditions

Cardiopulmonary Bypass

Keywords

Cardiopulmonary bypassCardiac SurgeryPlatelet function

Outcome Measures

Primary Outcomes (2)

  • Compare the diagnostic performance of the TEG®6S device and its Platelet mapping cartridge with that of the reference tests used in the hematology laboratory for the evaluation of platelet function

    Comparison of the results of reference tests used in the hematology laboratory for the evaluation of platelet function such as platelet aggregation in photometry (ADP, arachidonic acid, TRAP),with the results of the TEG® Platelet mapping® cartridge (MA fibrin, MA-ADP, MA-AA) obtained at the different pre, per and post-extracorporeal circulation sampling times

    6 hours after inclusion

  • Compare the diagnostic performance of the TEG®6S device and its Platelet mapping cartridge with that of the reference tests used in the hematology laboratory for the evaluation of platelet function

    Comparison of the results of reference tests used in the hematology laboratory for the evaluation of platelet function such as the results of total blood aggregometry by impedance (Multiplate®: TRAPtest, ASPItest and ADPtest), with the results of the TEG® Platelet mapping® cartridge (MA fibrin, MA-ADP, MA-AA) obtained at the different pre, per and post-extracorporeal circulation sampling times

    6 hours after inclusion

Secondary Outcomes (12)

  • Compare the diagnostic performance of the TEG®6S device and its Platelet mapping® cartridge with the reference tests used in the hematology laboratory for the prediction of the risk of post-cardiopulmonary bypass bleeding.

    24 hours after inclusion

  • Compare the diagnostic performance of the TEG®6S device and its Platelet mapping® cartridge with the reference tests used in the hematology laboratory for the prediction of the risk of post-cardiopulmonary bypass bleeding.

    24 hours after inclusion

  • Compare the diagnostic performance of the TEG®6S device and its Platelet mapping® cartridge with the reference tests used in the hematology laboratory for the prediction of the risk of post-cardiopulmonary bypass bleeding.

    24 hours after inclusion

  • Compare the diagnostic performance of the TEG®6S device and its Platelet mapping® cartridge with the reference tests used in the hematology laboratory for the prediction of the risk of post-cardiopulmonary bypass bleeding.

    24 hours after inclusion

  • Compare the diagnostic performance of the TEG®6S device and its Platelet mapping® cartridge with the reference tests used in the hematology laboratory for the prediction of the risk of post-cardiopulmonary bypass bleeding.

    24 hours after inclusion

  • +7 more secondary outcomes

Interventions

TEG®6S device with its Platelet mapping® cartridgeDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Major persons operated on for cardiac surgery under extracorporeal circulation

You may qualify if:

  • Patients scheduled to undergo cardiopulmonary bypass
  • Informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Département d'Anesthésie-Réanimation,Hopital Pitié Salpêtrière

Paris, 75013, France

Location

Study Officials

  • Adrien BOUGLE, MD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

  • Ahmed ABBES, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2020

First Posted

February 10, 2021

Study Start

April 21, 2021

Primary Completion

May 7, 2021

Study Completion

May 7, 2021

Last Updated

January 31, 2022

Record last verified: 2021-09

Locations

FR(1)