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

University Hospital, Strasbourg, France1 site in 1 country100 target enrollmentFebruary 4, 2025

ConditionsPlatelets Autotransfusion Device

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Platelets
Sponsor: University Hospital, Strasbourg, France
Enrollment: 100
Locations: 1
Primary Endpoint: Platelet count
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

February 4, 2025

End Date

September 8, 2026

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

University Hospital, Strasbourg, France

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

To study the evolution of platelet count following the use of the autotransfusion device (other than SAME) 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)
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.(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.(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.(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.(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.(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.(Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device)