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Blood Product

Platelet Transfusion for Bleeding in Children on ECMO (ECSTATIC Trial)

Phase 4
Recruiting
Led By Marianne Nellis, MD, MS
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Critically ill children (0 to <18 years of age) admitted to a participating pediatric, neonatal, or cardiac intensive care unit (PICU/NICU/CICU) on extracorporeal Membrane Oxygenation (ECMO) with either no bleeding or minimal bleeding within 24 hours of cannulation
Be younger than 65 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 21
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial studies how to safely transfuse platelets to critically ill children on ECMO to reduce risks of bleeding.

Who is the study for?
This trial is for critically ill children on ECMO with minimal or no bleeding. They must be between 0 to <18 years old, not have been on ECMO for more than 24 hours, and without certain conditions like cancer treatment in the last six months or congenital bleeding disorders.
What is being tested?
The ECSTATIC pilot trial is testing two strategies of platelet transfusions in children on ECMO: one uses a high threshold for when to give platelets, and the other a low threshold. The goal is to find out which strategy better prevents complications.
What are the potential side effects?
Potential side effects from platelet transfusions include reactions at the infusion site, increased risk of infections, allergic reactions, and complications related to blood clotting or excessive bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child is critically ill, under 18, in intensive care on ECMO, and has had no or minimal bleeding after the procedure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have received cancer treatment or a bone marrow transplant recently.
Select...
I have a bleeding disorder I was born with.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 21
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 21 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pre-transfusion platelet count
Total platelet transfusion dose
Secondary study objectives
Compliance with transfusion thresholds
Duration for temporary suspensions
Feasibility assessed by the inclusion rate
+4 more

Side effects data

From 2018 Phase 4 trial • 46 Patients • NCT03045068
14%
Arrhythmia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Study Group
Control Group

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Lower platelet transfusion strategyExperimental Treatment1 Intervention
Participants randomized to this arm will be transfused if the platelet count is \< 50 x 10e9 cells/L.
Group II: Higher platelet transfusion strategyActive Control1 Intervention
Participants randomized to this arm will be transfused if the platelet count is \< 90 x 10e9 cells/L.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Platelet Transfusion
2001
Completed Phase 4
~170

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityOTHER
719 Previous Clinical Trials
22,895,786 Total Patients Enrolled
Emory UniversityOTHER
1,708 Previous Clinical Trials
2,607,448 Total Patients Enrolled
University of RochesterOTHER
872 Previous Clinical Trials
550,041 Total Patients Enrolled
University of IowaOTHER
471 Previous Clinical Trials
894,611 Total Patients Enrolled
Schneider Medical Children's Center, IsraelUNKNOWN
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,797,849 Total Patients Enrolled
2 Trials studying Bleeding
3,450 Patients Enrolled for Bleeding
Columbia UniversityOTHER
1,498 Previous Clinical Trials
2,767,075 Total Patients Enrolled
3 Trials studying Bleeding
358 Patients Enrolled for Bleeding
Children's Hospital and Health System Foundation, WisconsinOTHER
55 Previous Clinical Trials
96,599 Total Patients Enrolled
Duke UniversityOTHER
2,463 Previous Clinical Trials
2,981,810 Total Patients Enrolled
1 Trials studying Bleeding
50 Patients Enrolled for Bleeding
Johns Hopkins All Children's HospitalOTHER
46 Previous Clinical Trials
5,008,434 Total Patients Enrolled

Media Library

Platelet Transfusion (Blood Product) Clinical Trial Eligibility Overview. Trial Name: NCT05796557 — Phase 4
Bleeding Research Study Groups: Higher platelet transfusion strategy, Lower platelet transfusion strategy
Platelet Transfusion (Blood Product) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05796557 — Phase 4
~10 spots leftby Apr 2025
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