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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age of 18 and older,
• supported by peripheral VA-ECMO
• for cardiogenic shock
• Life expentency \>90 days
• Central venous line available ScVO2 measurement
Locations
Other Locations
France
Service d'Anesthésie-Réanimation CCV Hôpital Cardiologique Centre Hospitalier et Universitaire de Lille
RECRUITING
Lille
Contact Information
Primary
Mouhamed MOUSSA, MD
mouhamed.moussa@chru-lille.fr
0320445962
Time Frame
Start Date: 2023-09-18
Estimated Completion Date: 2025-12-18
Participants
Target number of participants: 238
Treatments
Experimental: Individulised transfusion strategy group
Patients will recieve red blood cells transfusion in case of a drop of ScVO2 \<65% after an assessment for the optimisation of SaO2 normalisation (SaO2\>94%), volume optimisation, ECMO output increase, Fever (body temperature 38°3 C°), Anxiety and Pain
Active_comparator: Conventionnal transfusion strategy group
Transfusion will be performed in case of a hemoglobin drop \<9 g/dL
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital, Caen, Amiens University Hospital, Centre Hospitalier de Lens, Centre hospitalier de Dunkerque, Centre Hospitalier Universitaire Dijon, University Hospital, Rouen
Leads: University Hospital, Lille