Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-02-24 @ 7:49 AM
Study NCT ID:
NCT06766032
Status:
COMPLETED
Last Update Posted:
2025-01-09
First Post:
2024-12-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Performance and Effectiveness of Two Transfusion-Saving Devices: Cell-Saver and SAME
Sponsor:
Nantes University Hospital
Organization:
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAME-CELL
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: