Platelet and Autotransfusion Device in Cardiac Surgery (PLAQ-SES)

March 31, 2025 updated by: University Hospital, Strasbourg, France

Study of Platelet Count Changes During the Use of Autotransfusion Device in Cardiac Surgery

Cardiac surgery is a bleeding-risk surgery and frequently requires blood transfusion. Intraoperative autotransfusion devices are used to aspirate, process and retransfuse patients' blood. These devices are effective in recovering red blood cells and limiting the need for transfusion of packed red blood cells. Some devices, such as I-SEP's SAME®, can also be used to recover platelets, but their effectiveness has not yet been evaluated in real-life situations. The aim of this study is therefore to investigate the evolution of platelet counts following the use of an intraoperative recovery device in adult patients undergoing standard cardiac surgery

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Bas-Rhin
      • Strasbourg, Bas-Rhin, France, 67091
        • Recruiting
        • Hôpitaux Universitaires de Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients addressed in a university hospital for cardiac surgery

Description

Inclusion Criteria:

  • Patients over 18 years of age
  • Having undergone standard cardiac surgery (excluding redux surgery, dissection, endocarditis, circulatory assist and transplants)
  • Treated with an autotransfusion device during the surgery
  • Subject having expressed their consent to the study

Exclusion Criteria:

  • Anemia less than 7 g/dL
  • Pregnant women
  • Redux surgery, dissection, endocarditis, circulatory assistance, and transplants
  • Contraindication to the use of an autotransfusion device
  • Impossibility of giving the subject informed information

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet count
Time Frame: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
Study the evolution of platelet counts following the use of I-SEP's SAME™ autotransfusion device in major patients undergoing standard cardiac surgery
Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device

Secondary Outcome Measures

Outcome Measure
Time Frame
To study the evolution of platelet count following the use of the autotransfusion device (other than SAME) in major patients undergoing standard cardiac surgery.
Time Frame: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
To study the evolution of platelet function (flow cytometry and flow aggregation) following the use of a autotransfusion device in major patients undergoing standard cardiac surgery.
Time Frame: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
Study the evolution of platelet function according to the autotransfusion device used.
Time Frame: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
Study post-operative bleeding volume as a function of autotransfusion device type.
Time Frame: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
Study the volume of labile blood product transfusion according to the autotransfusion device used.
Time Frame: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
Study the intensity of post-operative inflammatory syndrome as a function of the autotransfusion device used.
Time Frame: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
Study platelet adhesion to the autotransfusion device membranes using electron microscopy.
Time Frame: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2025

Primary Completion (Estimated)

September 8, 2026

Study Completion (Estimated)

September 8, 2026

Study Registration Dates

First Submitted

October 3, 2024

First Submitted That Met QC Criteria

October 3, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 9264

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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