Comparing individualized and conventional blood transfusion strategies during ECMO for heart failure
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
Run by University Hospital, Lille · NCT05699005 · Data updated 2026-11-12
This study is testing whether a personalized blood transfusion approach during heart support treatment can help patients use less blood and have better outcomes compared to the standard method.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 236 (estimated) |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 4 sites (Lille, NORD and 3 other locations) |
| Status | Recruiting |
| Started | September 18, 2023 |
| Main results expected | March 18, 2028 |
| Study ends | December 18, 2028 |
| Registry record updated | September 17, 2026 |
| Trial ID | NCT05699005 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who are supported by peripheral VA-ECMO for cardiogenic shock and have a life expectancy greater than 90 days.
✕Probably not a fit
Patients who are pregnant, lack health insurance, oppose blood transfusions, or have specific medical conditions such as congenital hemoglobin disorders will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter randomized controlled trial aims to compare two strategies for red blood cell transfusion in patients undergoing veno-arterial extracorporeal membrane oxygenation (VA-ECMO) due to refractory cardiogenic shock. One strategy is individualized based on ScVO2 levels, while the other follows a conventional approach based on predefined hemoglobin thresholds. The primary endpoint is the amount of packed red blood cells consumed, with secondary endpoints including mortality, morbidity, and cost-effectiveness. The study seeks to address the high consumption of blood products and associated complications in this patient population.
Why it matters
Potential benefit: If successful, this study could lead to more effective and safer transfusion practices for patients on VA-ECMO, potentially reducing complications and improving outcomes.
How similar studies have gone: While there is limited consensus on transfusion strategies in this specific population, previous studies have indicated potential benefits of individualized approaches, suggesting this study could provide valuable insights.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age of 18 and older, * supported by peripheral VA-ECMO * for cardiogenic shock * Life expentency \>90 days * Central venous line available ScVO2 measurement Exclusion Criteria: * Pregnancy, * Lack of health insurance, * Opposition to blood transfusion, * Known congenital hemoglobin disease or disorder, * Metabolic alcaloosis with pH\>7.8, * eCPR, * Legally incapacitated adults
Where it's running
-
Service d'Anesthésie-Réanimation CCV Hôpital Cardiologique Centre Hospitalier et Universitaire de Lille
Lille, Nord, France Recruiting -
CHU Amiens
Amiens, France Recruiting -
CHU Dijon
Dijon, France Recruiting -
Centre de Réanimation, Hôpital Salengro, CHU Lille
Lille, France Recruiting
Study contacts
- Principal investigator: Mouhamed MOUSSA, MD — University Hospital, Lille
- Study coordinator: Mouhamed MOUSSA, MD
- Email: mouhamed.moussa@chru-lille.fr
- Phone: 0320445962
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.