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

Completed

• Conditions: Cardiac Surgery Under Extra Corporeal Circulation; Cardiac Surgery Requiring Cardiopulmonary Bypass

• Registration Number: NCT06766032
• Lead Sponsor: Nantes University Hospital

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.

Study Timeline

• Study Start: 2021-06-05
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-28
• Study First Submitted: 2024-12-16
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-03
• Last Update Submitted: 2025-01-03
• Study First Posted: 2025-01-09
• Last Update Posted: 2025-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

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).

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference between the preoperative and immediate postoperative platelet counts (delta of platelet) for each patient	up to 1 week	The main outcome measure is the difference between the preoperative and immediate postoperative platelet counts (delta platelet) for each patient in the Cell-saver group or in the SAME group.

Secondary Outcome Measures

Name	Time	Method
Postoperative platelet	5 days	Postoperative platelet count between day 1 and day 5
Perioperative and postoperative transfusions	28 days	Frequency of perioperative and postoperative transfusions, number and type of blood products transfused from surgery (day 1) to 28 days after surgery
Durations of stays	28 days	Duration of stays in the intensive care unit and in the hospital from surgery (day 1) to 28 days after surgery
Derivative medications	28 days	Use of derivative medications (fibrinogen, prothrombin complex concentrates) from surgery (day 1) to 28 days after surgery
Postoperative bleeding	28 days	Volume of postoperative bleeding from surgery (day 1) to 28 days after surgery
Postoperative events	28 days	Frequency of postoperative events (infectious, renal, thromboembolic, hemorrhagic) from surgery (day 1) to 28 days after surgery
Postoperative anemia	28 days	Frequency of treatment for postoperative anemia with iron or erythropoiesis-stimulating agents from surgery (day 1) to 28 days after surgery

Trial Locations

Locations (1)

CHU de Nantes; 🇫🇷 Nantes, France