Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05699005
Status:
RECRUITING
Last Update Posted:
2024-04-04
First Post:
2022-12-21
Brief Title:
Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO
Sponsor:
University Hospital Lille
Organization:
University Hospital Lille
Study Overview
Official Title:
Comparison of an Individualized Transfusion Strategy to a Conventional Strategy in Patients Undergoing Peripheral Veno-arterial ECMO for Refractory Cardiogenic Shock a Randomized Controlled Trial - ICONE
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:
ICONE
Brief Summary:
This multicenter randomized controlled trial compare two transfusion strategies of red blood cells transfusion in patients supported by veno-arterial extracorporeal membrane oxygenation for refractory cardiogenic shock
An individualized transfusion strategy based on ScVO2 level is compared to a conventionnal strategy based on predefined hemoglobin threshold The primary endpoint is the consumption of packed red blod cells secondary endpoints are subgroup analysis mortality morbidity and cost-effectiveness
An individualized transfusion strategy based on ScVO2 level is compared to a conventionnal strategy based on predefined hemoglobin threshold The primary endpoint is the consumption of packed red blod cells secondary endpoints are subgroup analysis mortality morbidity and cost-effectiveness
Detailed Description:
Peripheral VA-ECMO is the mainstay of mechanical circulatory support in refractory cardiogenic shock This treatment is associated with a high consumption of packed red blood cells PRBCs which can reach 1 to 3 units of PRBCs per day of support The main reasons for such a high consumption of PRBCs are the very frequent hemorrhagic complications and the prevalence of anemias not directly related to the hemorrhagic episodes These anemias are frequent during VA-ECMO support owing to hemolysis hemodilution previous bleeding episodes thrombosis etc
In order to restore maintain or increase oxygen delivery DO2 to peripheral organs RGCs are often performed when anemia is observed Several studies have reported an association between transfusion of these PRBCs with morbidity and mortality in this ECMO setting
There is no appropriate strategy to reduce PRBC consumption taking into account other determinants of DO2 In addition there is currently no validated or consensus hemoglobin threshold to guide transfusion in this specific population Furthermore this predefined threshold-based approach may be inappropriate in the setting of VA-ECMO due to differences in DO2 requirements between patients based on their etiology disease severity and ECMO modality In addition large variations in DO2 can be observed in the same patient and between ECMO settings Therefore a more individualized strategy guided by a DO2 surrogate ScVO2 may be more appropriate in this population This ScVO2 approach has recently been shown to be associated with reduced PRBCs in two randomized controlled trials in cardiac surgery patients
The objective of this multicenter randomized controlled trial is to compare two red cell transfusion strategies in patients receiving extracorporeal veno-arterial membrane oxygenation for refractory cardiogenic shock
An individualized transfusion strategy based on ScVO2 level is compared with a conventional strategy based on a predefined hemoglobin threshold The primary endpoint is red blood cell consumption the secondary endpoints are subgroup analysis mortality morbidity and cost-effectiveness
In order to restore maintain or increase oxygen delivery DO2 to peripheral organs RGCs are often performed when anemia is observed Several studies have reported an association between transfusion of these PRBCs with morbidity and mortality in this ECMO setting
There is no appropriate strategy to reduce PRBC consumption taking into account other determinants of DO2 In addition there is currently no validated or consensus hemoglobin threshold to guide transfusion in this specific population Furthermore this predefined threshold-based approach may be inappropriate in the setting of VA-ECMO due to differences in DO2 requirements between patients based on their etiology disease severity and ECMO modality In addition large variations in DO2 can be observed in the same patient and between ECMO settings Therefore a more individualized strategy guided by a DO2 surrogate ScVO2 may be more appropriate in this population This ScVO2 approach has recently been shown to be associated with reduced PRBCs in two randomized controlled trials in cardiac surgery patients
The objective of this multicenter randomized controlled trial is to compare two red cell transfusion strategies in patients receiving extracorporeal veno-arterial membrane oxygenation for refractory cardiogenic shock
An individualized transfusion strategy based on ScVO2 level is compared with a conventional strategy based on a predefined hemoglobin threshold The primary endpoint is red blood cell consumption the secondary endpoints are subgroup analysis mortality morbidity and cost-effectiveness
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-A01925-36 | OTHER | None | None |
| PHRCI-19-032 | OTHER | AAP number DGOS | None |