Phase 4
N=50
ECMO Hemostatic Transfusions in Children
Extracorporeal Membrane Oxygenation Complication · Hemorrhage · Thromboembolism · Transfusion Adverse Reaction
Bottom Line
View on ClinicalTrials.gov: NCT05796557 ↗Enrolled (actual)
50
Serious AEs
18.0%
Results posted
May 2025
Primary outcome: Primary: Total Platelet Transfusion Dose — 7.4; 0 mL/kg/day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Platelet Transfusion (Biological)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Platelet Transfusion Dose |
7.4; 0 | — |
| PRIMARY Pre-transfusion Platelet Count |
79; 43 | — |
| SECONDARY Feasibility Assessed by the Screening Rate |
123 | — |
| SECONDARY Feasibility Assessed by the Inclusion Rate |
50 | — |
| SECONDARY Feasibility Assessed by the Number of Informed Consents Signed in the First 24 Hours Post Cannulation. |
50 | — |
| SECONDARY Compliance With Transfusion Thresholds |
316; 386 | — |
| SECONDARY Participants With at Least One Temporary Suspension |
6; 8 | — |
| SECONDARY Duration for Temporary Suspensions |
7.5; 13.5 | — |
| SECONDARY Progression to Composite Outcome of Severe Bleeding and/or Severe Thrombotic Event |
4; 5 | — |
| SECONDARY Number of Participants Who Were Withdrawn and/or Lost to Follow-up |
2; 2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Critically ill children (0 to 24 hours at time of enrollment
Data sourced from ClinicalTrials.gov (NCT05796557). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.