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

Comparison of the Performance and Effectiveness of Two Transfusion-Saving Devices: Cell-Saver for Red Blood Cell Reinfusion and SAME for Red Blood Cell and Platelet Reinfusion

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery Requiring Cardiopulmonary Bypass; Cardiac Surgery Under Extra Corporeal Circulation
• Intervention / Treatment: Device: CELL-Saver; Device: SAME

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 Type: Observational
• Enrollment (Actual): 304

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • CHU de Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients treated by the cardiac surgery department of Nantes University Hospital who undergo a cardiovascular procedure with cardiopulmonary bypass considered to be at high risk for bleeding; (prolonged cardiopulmonary bypass >2 hours, aortic arch surgery, history of redo cardiac surgery, combined surgery, multiple portocoronary bypasses). Procedures for which a perioperative blood recovery device (SAME or Cell-Saver) has been used, with the choice of the blood recovery technique at the discretion of the medical team.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cell-Saver group; Patients for whom the Cell-saver device is used during cardiac surgery.	Device: CELL-Saver; 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.	Device: SAME; The SAME device allows for red blood cell and platelet reinfusion during cardiac surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between the preoperative and immediate postoperative platelet counts (delta of platelet) for each patient	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.	up to 1 week

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Mickaël Vourc'h, MD-PhD, Nantes HU

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2021
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): July 28, 2024

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: January 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 3, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: cell-saver; platelet transfusion; auto-transfusion; blood saving techniques
• Other Study ID Numbers: AR_2024_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No