Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05740059
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2023-02-06
Brief Title:
Restrictive Transfusion StratEgy Adjusted by SvO2 During Cardiac Surgery
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Restrictive Transfusion StratEgy Adjusted by SvO2 During Cardiac Surgery Multicenter Single-blinded Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-01
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:
RETSEACSII
Brief Summary:
The goal of the clinical trial is to evaluate whether a restrictive transfusion strategy adjusted by SvO2 during the perioperative period of cardiac surgery may reduce the incidence of red blood cell transfusion Adult patients operated on cardiac surgery will be randomly allocated into two groups one receiving standard restrictive transfusion the other receiving SvO2 adjusted restrictive transfusionThe proportion of patients transfused will be compared between the 2 groups
Detailed Description:
Cardiac surgery represents only a small fraction of all surgical procedures but consumes a significant proportion of the stored red blood cells RBC with almost 50 of patients receiving a perioperative transfusion Since RBC transfusion is associated with an increased risk of morbidity and mortality blood patient management strategy has been promoted to favour prevention of anaemia reduction of bleeding and limitation of transfusion Current guidelines recommend haemoglobin Hb threshold as low as 7 gdL but still with a wide possible range 7 to 9 gdl and suggest that Hb alone may not be the best criteria for triggering transfusion As Hb is an oxygen carrier the rationale for RBC transfusion should be to increase tissue oxygen delivery Central venous oxygen saturation central SvO2 which is related to the balance between tissue oxygen delivery and consumption is easily measurable in cardiac surgery In a previous study the investigators showed that in anaemic patients having undergone cardiac surgery restrictive transfusion according to central SvO2 allowed a significant reduction in RBC transfusion incidence in the ICU The investigators hypothesize that a restrictive transfusion strategy adjusted by SvO2 during all the perioperative period of cardiac surgery may reduce further the incidence of RBC transfusion Limiting RBC transfusion to patients with a low SvO2 could save unnecessary transfusions without increasing the anaemia related risk
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None