ECMO Hemostatic Transfusions in Children

Completed · Phase 4

Conditions studied: Extracorporeal Membrane Oxygenation Complication, Hemorrhage, Thromboembolism, Transfusion Adverse Reaction

In brief

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.

Key facts

Study ID

NCT05796557

Run by

Yale University

People needed

50

Starts

2023-12-12

Expected to finish

2025-03-25

Last updated by the study team

2025-05-31

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Healthcare of Atlanta - Emory — Atlanta, Georgia, United States
• University of Iowa Health Care — Iowa City, Iowa, United States
• Norton Children's Hospital — Louisville, Kentucky, United States
• Morgan Stanley Children's Hospital of New York Presbyterian — New York, New York, United States
• Komansky Children's Hospital of New York Presbyterian — New York, New York, United States
• Golisano Children's Hospital — Rochester, New York, United States
• Duke University School of Medicine — Durham, North Carolina, United States
• Children's Hospital of Richmond at VCU — Richmond, Virginia, United States
• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States
• Schneider Children's Medical Center — Petah Tikva, Israel

Full record on ClinicalTrials.gov

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