Comparing individualized and conventional blood transfusion strategies during ECMO for heart failure
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
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 |
| Enrollment | 238 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille, Nord) |
| Trial ID | NCT05699005 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Lille, Nord
- Service d'Anesthésie-Réanimation CCV Hôpital Cardiologique Centre Hospitalier et Universitaire de Lille — Lille, Nord, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.