NCT05699005 Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO
| NCT ID | NCT05699005 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University Hospital, Lille |
| Condition | Cardiogenic Shock |
| Study Type | INTERVENTIONAL |
| Enrollment | 236 participants |
| Start Date | 2023-09-18 |
| Primary Completion | 2028-03-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 236 participants in total. It began in 2023-09-18 with a primary completion date of 2028-03-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility 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
Contact & Investigator
Mouhamed MOUSSA, MD
PRINCIPAL INVESTIGATOR
University Hospital, Lille
Frequently Asked Questions
Who can join the NCT05699005 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiogenic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05699005 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05699005 currently recruiting?
Yes, NCT05699005 is actively recruiting participants. Contact the research team at mouhamed.moussa@chru-lille.fr for enrollment information.
Where is the NCT05699005 trial being conducted?
This trial is being conducted at Lille, France.
Who is sponsoring the NCT05699005 clinical trial?
NCT05699005 is sponsored by University Hospital, Lille. The principal investigator is Mouhamed MOUSSA, MD at University Hospital, Lille. The trial plans to enroll 236 participants.