CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 50 enrolled
Drug / intervention
Platelet Transfusionbiological
Likely dose
Platelet Transfusion 10 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05796557
NCT05796557Phase 4Completed
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ECMO Hemostatic Transfusions in Children

Yale University·interventional·Posted Apr 3, 2023·Updated May 31, 2025

In Brief

A Phase 4 clinical trial evaluating Platelet Transfusion for Extracorporeal Membrane Oxygenation Complication and 3 related conditions. Completed, enrolled 50 participants across 10 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsExtracorporeal Membrane Oxygenation Complication, Hemorrhage, Thromboembolism, Transfusion Adverse Reaction
CountriesIsrael, United States
CollaboratorsWeill Medical College of Cornell University, University of Utah, National Heart, Lung, and Blood Institute (NHLBI), Columbia University, Virginia Commonwealth University, University of Rochester, Children's Hospital and Health System Foundation, Wisconsin, Duke University, Johns Hopkins All Children's Hospital, University of Iowa, Emory University, Schneider Children's Medical Center, Israel

Timeline

Phase 4CompletedFinished
202420252026
First PostedApr 3, 2023
Enrollment StartDec 12, 2023
Primary CompletionJan 2, 2025
Study CompletionMar 25, 2025
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 3.2 years ago

Interventions

Platelet Transfusionbiological

Participants will be transfused according to the assigned threshold for each group, with a transfusion dose of 10 mL/kg, up to one adult unit.