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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 21
Awards & highlights

ECSTATIC 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.Check my eligibility
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.See study design
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.

ECSTATIC Trial 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.

ECSTATIC Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pre-transfusion platelet count
Total platelet transfusion dose
Secondary outcome measures
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
29%
Arrhythmia
19%
Cardiopulmonary Resuscitation (CPR) Event
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control Group
Study Group

ECSTATIC 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
699 Previous Clinical Trials
22,884,995 Total Patients Enrolled
Emory UniversityOTHER
1,640 Previous Clinical Trials
2,560,607 Total Patients Enrolled
University of RochesterOTHER
840 Previous Clinical Trials
534,200 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How hazardous is the practice of providing low platelet transfusions to individuals?

"The safety of lower platelet transfusion strategy is rated a 3, since it has reached Phase 4 in the clinical trial process, and therefore meets all necessary criteria for approval."

Answered by AI

What are the main goals that this medical experiment is aiming to achieve?

"This medical trial, that will be evaluated over a 21-day period, is aimed at assessing total platelet transfusion dose. Secondary objectives include evaluating feasibility by screening rate and number of informed consents signed within 24 hours post cannulation as well as determining compliance with transfusion thresholds."

Answered by AI

Does this trial currently need any more participants?

"Data hosted on clinicaltrials.gov reveals that, although initially posted July 1st 2023 and last updated March 30th 2023, this particular trial is not taking in any more patients at present. Nonetheless, 444 other trials are presently recruiting participants."

Answered by AI

How far-reaching is the geographic reach of this clinical trial?

"A total of 10 medical centres are currently enrolling patients for the clinical trial, including Children's Healthcare of Atlanta - Emory in Atlanta, University of Iowa Health Care in Iowa City and Morgan Stanley Chidren's Hospital of New york Presbyterian. The other recruiters can be found listed on our website."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
ECMO Hemostatic Transfusions in Children
2023. "ECMO Hemostatic Transfusions in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05796557.
All > Ecmo
~33 spots leftby Apr 2025
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