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

NCT06766032 | Completed

• 1 other identifier: AR_2024_001
• Study Type: observational
• Target: 304
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

cell-saver; auto-transfusion; platelet transfusion; blood saving techniques

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Postoperative platelet

  5 days

• Perioperative and postoperative transfusions

  28 days

• Derivative medications

  28 days

• Postoperative bleeding

  28 days

• Postoperative events

  28 days

Study Arms (2)

Cell-Saver group

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

Device: CELL-Saver

SAME group

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

Device: SAME

Interventions

CELL-Saver DEVICE

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

Cell-Saver group

SAME DEVICE

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

SAME group

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

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.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, 44093, France

Location

MeSH Terms

Interventions

Operative Blood Salvage

Intervention Hierarchy (Ancestors)

Tissue and Organ Harvesting; Transplantation; Surgical Procedures, Operative

Study Officials

• Mickaël Vourc'h, MD-PhD

  Nantes HU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: January 9, 2025
• Study Start: June 5, 2021
• Primary Completion: July 1, 2024
• Study Completion: July 28, 2024
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

FR (1)