Platelet and Autotransfusion Device in Cardiac Surgery

NCT06629311 | Recruiting

• 1 other identifier: 9264
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Platelets; Autotransfusion Device

Keywords

Cardiac surgery; Autotransfusion device; Platelets

Outcome Measures

Primary Outcomes (1)

• Platelet count

  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 Outcomes (7)

• 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

Interventions

Autotransfusion device DEVICE

Standard cardiac surgery using I-SEP and SAME™ autotransfusion device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients addressed in a university hospital for cardiac surgery

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, Bas-Rhin, 67091, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Platelet-poor plasma Used autotransfusion device

Central Study Contacts

Charles TACQUARD, PHU

CONTACT

+33 6 69 55 16 08; charlesambroise.tacquard@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 32 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 8, 2024
• Study Start: February 4, 2025
• Primary Completion (Estimated): September 8, 2026
• Study Completion (Estimated): September 8, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)