Skip to main content
OpenTrials
Completed

NCT Number: NCT06766032

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiac Surgery Under Extra Corporeal Circulation Cardiac Surgery Requiring Cardiopulmonary Bypass

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nantes

Nantes, 44093, France

About this study

° 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CELL-Saver

Device

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

SAME

Device

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

Primary outcomes

  1. Difference between the preoperative and immediate postoperative platelet counts (delta of platelet) for each patient

    Time frame: 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 outcomes

  1. Postoperative platelet

    Time frame: 5 days

    Postoperative platelet count between day 1 and day 5

  2. Perioperative and postoperative transfusions

    Time frame: 28 days

    Frequency of perioperative and postoperative transfusions, number and type of blood products transfused from surgery (day 1) to 28 days after surgery

  3. Derivative medications

    Time frame: 28 days

    Use of derivative medications (fibrinogen, prothrombin complex concentrates) from surgery (day 1) to 28 days after surgery

  4. Postoperative bleeding

    Time frame: 28 days

    Volume of postoperative bleeding from surgery (day 1) to 28 days after surgery

  5. Postoperative events

    Time frame: 28 days

    Frequency of postoperative events (infectious, renal, thromboembolic, hemorrhagic) from surgery (day 1) to 28 days after surgery

  6. Durations of stays

    Time frame: 28 days

    Duration of stays in the intensive care unit and in the hospital from surgery (day 1) to 28 days after surgery

  7. Postoperative anemia

    Time frame: 28 days

    Frequency of treatment for postoperative anemia with iron or erythropoiesis-stimulating agents from surgery (day 1) to 28 days after surgery

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: SAME-CELL

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 9, 2025
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.