Comparison of the Performance and Effectiveness of Two Transfusion-Saving Devices: Cell-Saver and SAME

NCT ID: NCT06766032

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 304 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-05
• Study Completion Date: 2024-07-28

Brief Summary

An observational study comparing two systems of perioperative blood recovery in cardiac surgery, one system allowing red blood cell reinfusion and one system allowing red blood cell and platelet reinfusion. The objective is to evaluate whether platelet recovery provides better quality of hemostasis during and after surgery, improving transfusion savings, and whether it reduces postoperative complications and the length of stay in the intensive care unit and in the hospital.

Detailed Description

° Primary outcome of the study : The primary outcome of the study is to compare the evolution of perioperative platelet count based on the type of blood recovery used, either SAME or Cell-Saver.

The main outcome measure is the difference between the preoperative and immediate postoperative platelet counts (delta platelet) for each patient between the SAME and Cell-Saver groups.

° Secondary outcomes of the study:

The secondary outcomes are to evaluate, from the preoperative period until day 28 postoperatively:

• The post-operative platelet count between days 1 and 5
• The frequency of perioperative and postoperative transfusions, including the number and type of blood products transfused
• The use of derivative medications (fibrinogen, prothrombin complex concentrates)
• The volume of postoperative bleeding
• The frequency of postoperative events (infectious, renal, thromboembolic, hemorrhagic)
• The length of stay in the intensive care unit and in the hospital
• The frequency of treatment for postoperative anemia with iron or erythropoiesis-stimulating agents.

Conditions

Cardiac Surgery Under Extra Corporeal Circulation; Cardiac Surgery Requiring Cardiopulmonary Bypass

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Cell-Saver group

Patients for whom the Cell-saver device is used during cardiac surgery.

CELL-Saver

Intervention Type: DEVICE

The Cell-saver device allows for red blood cell reinfusion during cardiac surgery.

SAME group

Patients for whom the SAME device is used during cardiac surgery.

SAME

Intervention Type: DEVICE

The SAME device allows for red blood cell and platelet reinfusion during cardiac surgery.

Interventions

CELL-Saver

The Cell-saver device allows for red blood cell reinfusion during cardiac surgery.

Intervention Type: DEVICE

SAME

The SAME device allows for red blood cell and platelet reinfusion during cardiac surgery.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Scheduled cardiac surgery under cardiopulmonary bypass with a predicted duration of more than 2 hours, or surgery of the aortic arch, redo surgery, multiple aorto-coronary bypasses (>2), or combined surgery (valvular and coronary).

Exclusion Criteria

• Pre-existing constitutional or acquired bleeding disorder (hemophilia A or B, von Willebrand disease, myelodysplastic/myeloproliferative syndrome)
• Patients with sepsis, a malignant tumor at the surgical site, or contamination of recovered blood with biological fluids/antiseptics/distilled water/local antibiotics/hemostatic agents.
• Organ transplantation and planned circulatory support in the preoperative period
• Uni-bi-ventricular artificial heart
• Reoperation in a patient already included in the study
• Patient refusing blood transfusion
• Pregnant women
• Legally Protected adults

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mickaël Vourc'h, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Nantes HU

Locations

CHU de Nantes

Nantes, , France

Countries

France

Other Identifiers

AR_2024_001

Identifier Type: -

Identifier Source: org_study_id