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Cardiopulmonary BypassTEG-PMNCT04746560

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

An observational study of Cardiopulmonary Bypass, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiopulmonary Bypass
What is being tested?
TEG®6S device with its Platelet mapping® cartridge
Type of treatment
Medical device
How many people
6 participants
Where
1 siteFrance
Study dates
21 Apr 2021to 7 May 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Major persons operated on for cardiac surgery under extracorporeal circulation

Who may be able to join

  • Patients scheduled to undergo cardiopulmonary bypass
  • Informed consent

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Département d'Anesthésie-Réanimation,Hopital Pitié Salpêtrière

    Paris, 75013

Other trials in France

About this study

Official title: Evaluation of the Diagnostic Performances of the TEG 6s® Hemostasis Device and Its Platelet Mapping® Cartridge for Perioperative Monitoring of Platelet Function During Cardiopulmonary Bypass for Cardiac Surgery

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.

Read the 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.

Being tested
TEG®6S device with its Platelet mapping® cartridge
Keywords
Cardiopulmonary bypass, Cardiac Surgery, Platelet function

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TEG®6S device with its Platelet mapping® cartridgeDevice

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 hours after inclusion

  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 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

    Measured: 6 hours after inclusion

Secondary outcomes (12)

  1. 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.

    Compare results obtained at different sampling times (pre, per and post-extracorporeal circulation) of 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, using: ・ The results of platelet aggregation in photometry (ADP, arachidonic acid, TRAP)

    Measured: 24 hours after inclusion

  2. 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.

    Compare results obtained at different sampling times (pre, per and post-extracorporeal circulation) of 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, using The results of total blood aggregometry by impedance (Multiplate®: TRAPtest, ASPItest and ADPtest)

    Measured: 24 hours after inclusion

  3. 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.

    Compare results obtained at different sampling times (pre, per and post-extracorporeal circulation) of 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, using TEG® Platelet mapping® cartridge results (MA fibrin, MA-ADP, MA-AA)

    Measured: 24 hours after inclusion

  4. 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.

    Compare results obtained at different sampling times (pre, per and post-extracorporeal circulation) of 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, using Global Haemostasis® cartridge results (R and K times, angle, amplitudes MA, A30 and A60) obtained at different sampling times

    Measured: 24 hours after inclusion

  5. 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.

    Compare results obtained at different sampling times (pre, per and post-extracorporeal circulation) of 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, using Number and type of blood products transfused at the 24th hour after surgery

    Measured: 24 hours after inclusion

  6. 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.

    Compare results obtained at different sampling times (pre, per and post-extracorporeal circulation) of 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, using

    ・ The amount of bleeding in the drains at the 24th hour after surgery

    Measured: 24 hours after inclusion

  7. Evaluate the diagnostic performance of the TEG®6S device and its Global Haemostasis® cartridge in predicting the risk of bleeding at the end of cardiopulmonary bypass

    Evaluate the diagnostic performance of the TEG®6S device and its Global Haemostasis® cartridge in predicting the risk of bleeding at the end of cardiopulmonary bypass by statistical analysis of: ・ The results of platelet aggregation in photometry (ADP, arachidonic acid, TRAP)

    Measured: 24 hours after inclusion

  8. Evaluate the diagnostic performance of the TEG®6S device and its Global Haemostasis® cartridge in predicting the risk of bleeding at the end of cardiopulmonary bypass

    Evaluate the diagnostic performance of the TEG®6S device and its Global Haemostasis® cartridge in predicting the risk of bleeding at the end of cardiopulmonary bypass by statistical analysis of: ・ The results of total blood aggregometry by impedance (Multiplate®: TRAPtest, ASPItest and ADPtest)

    Measured: 24 hours after inclusion

  9. Evaluate the diagnostic performance of the TEG®6S device and its Global Haemostasis® cartridge in predicting the risk of bleeding at the end of cardiopulmonary bypass

    Evaluate the diagnostic performance of the TEG®6S device and its Global Haemostasis® cartridge in predicting the risk of bleeding at the end of cardiopulmonary bypass by statistical analysis of: ・ TEG® Platelet mapping® cartridge results (MA fibrin, MA-ADP, MA-AA)

    Measured: 24 hours after inclusion

  10. Evaluate the diagnostic performance of the TEG®6S device and its Global Haemostasis® cartridge in predicting the risk of bleeding at the end of cardiopulmonary bypass

    Evaluate the diagnostic performance of the TEG®6S device and its Global Haemostasis® cartridge in predicting the risk of bleeding at the end of cardiopulmonary bypass by statistical analysis of: ・ Global Haemostasis® cartridge results (R and K times, angle, amplitudes MA, A30 and A60) ; obtained at different sampling times

    Measured: 24 hours after inclusion

  11. Evaluate the diagnostic performance of the TEG®6S device and its Global Haemostasis® cartridge in predicting the risk of bleeding at the end of cardiopulmonary bypass

    Evaluate the diagnostic performance of the TEG®6S device and its Global Haemostasis® cartridge in predicting the risk of bleeding at the end of cardiopulmonary bypass by statistical analysis of: ・ Number and type of blood products transfused at the 24th hour after surgery

    Measured: 24 hours after inclusion

  12. Evaluate the diagnostic performance of the TEG®6S device and its Global Haemostasis® cartridge in predicting the risk of bleeding at the end of cardiopulmonary bypass

    Evaluate the diagnostic performance of the TEG®6S device and its Global Haemostasis® cartridge in predicting the risk of bleeding at the end of cardiopulmonary bypass by statistical analysis of: ・ The amount of bleeding in the drains at the 24th hour after surgery

    Measured: 24 hours after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2021
  2. Study start21 Apr 2021
  3. Primary completion7 May 2021
  4. Study completion7 May 2021

Why it stopped: Haemonetics, the company that manages the TEG device, has given a negative answer as to the continuation of the study. For technical and internal reasons, they will take over the device.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04746560
Sponsor's protocol ID
APHP201216
Acronym
TEG-PM
Status last verified
Sep 2021
First submitted
11 Dec 2020
Last updated
31 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiopulmonary Bypass, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Haemonetics, the company that manages the TEG device, has given a negative answer as to the continuation of the study. For technical and internal reasons, they will take over the device.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 6 hours after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04746560.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2022.

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