ECMO Hemostatic Transfusions in Children (NCT05796557) | Clinical Trial Compass
CompletedPhase 4
ECMO Hemostatic Transfusions in Children
United States, Israel50 participantsStarted 2023-12-12
Plain-language summary
Critically ill children supported by extracorporeal membrane oxygenation (ECMO) receive large volumes of prophylactic platelet transfusions to prevent bleeding. However, mounting evidence has demonstrated significant morbidity and mortality associated with these transfusions. The ECmo hemoSTAtic Transfusions In Children (ECSTATIC) pilot trial will test two different platelet transfusion strategies, based on two different platelet counts thresholds, one high (higher platelet transfusion strategy) and one low (lower platelet transfusion strategy). The pilot will gather the necessary information to perform a full trial which will provide a better understanding of how to transfuse platelets to children supported by ECMO and reduce the associated morbidity.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Critically ill children (0 to \<18 years of age)
* Admitted to a participating pediatric, neonatal, or cardiac intensive care unite (PICU/NICU/CICU)
* On extracorporeal Membrane Oxygenation (ECMO)
* Who have either no bleeding or minimal bleeding, within 24 hours of cannulation. Minimal bleeding is defined as:
* streaks of blood in endotracheal tube or during suctioning only
* streaks of blood in nasogastric tube
* macroscopic hematuria
* subcutaneous bleeding (including hematoma and petechiae) \< 5 cm in diameter
* quantifiable bleeding \< 1mL/kg/hr (e.g., chest tube)
* bloody dressings required to be changed no more often than each 6hr, or weighing no more than 1mL/kg/hr if weighed, due to slow saturation
Exclusion Criteria:
* Post-conception age \< 37 weeks at time of screening
* Underlying oncologic diagnosis (defined as receipt of chemotherapy or radiation in the last six months) or recipient of bone marrow transplant in the last year
* Congenital bleeding disorder
* Pregnant or admitted post-partum
* Decision to withdraw or withhold some critical care or interventions
* Known objection to blood transfusions
* On ECMO for \> 24 hours at time of enrollment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.