Platelet and Autotransfusion Device in Cardiac Surgery

Recruiting

• Conditions: Platelets; Autotransfusion Device

• Registration Number: NCT06629311
• Lead Sponsor: University Hospital, Strasbourg, France

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-03
• Study First Submitted QC: 2024-10-03
• Study First Posted: 2024-10-08
• Study Start: 2025-02-04
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03
• Primary Completion: 2026-09-08
• Study Completion: 2026-09-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Platelet count	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, Bas-Rhin, France