ECMO Hemostatic Transfusions in Children
ECSTATIC
2 other identifiers
interventional
50
2 countries
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2023
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2023
CompletedFirst Posted
Study publicly available on registry
April 3, 2023
CompletedStudy Start
First participant enrolled
December 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 2, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2025
CompletedResults Posted
Study results publicly available
May 31, 2025
CompletedMay 31, 2025
May 1, 2025
1.1 years
March 17, 2023
April 21, 2025
May 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Total Platelet Transfusion Dose
The total dose (in mL/kg/day) will be computed by the research team, by dividing the total platelet transfusion volume by the patient's weight at admission and the number of days of intervention.
up to day 21
Pre-transfusion Platelet Count
Pre-transfusion platelet count, during intervention
During intervention
Secondary Outcomes (8)
Feasibility Assessed by the Screening Rate
At screening
Feasibility Assessed by the Inclusion Rate
At screening
Feasibility Assessed by the Number of Informed Consents Signed in the First 24 Hours Post Cannulation.
At screening
Compliance With Transfusion Thresholds
up to Day 21
Participants With at Least One Temporary Suspension
up to Day 21
- +3 more secondary outcomes
Study Arms (2)
Higher platelet transfusion strategy
ACTIVE COMPARATORParticipants randomized to this arm will be transfused if the platelet count is \< 90 x 10e9 cells/L.
Lower platelet transfusion strategy
EXPERIMENTALParticipants randomized to this arm will be transfused if the platelet count is \< 50 x 10e9 cells/L.
Interventions
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- Weill Medical College of Cornell Universitycollaborator
- University of Utahcollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Columbia Universitycollaborator
- Virginia Commonwealth Universitycollaborator
- University of Rochestercollaborator
- Children's Hospital and Health System Foundation, Wisconsincollaborator
- Duke Universitycollaborator
- Johns Hopkins All Children's Hospitalcollaborator
- University of Iowacollaborator
- Emory Universitycollaborator
- Schneider Medical Children's Center, Israelcollaborator
Study Sites (10)
Children's Healthcare of Atlanta - Emory
Atlanta, Georgia, 30322, United States
University of Iowa Health Care
Iowa City, Iowa, 52242, United States
Norton Children's Hospital
Louisville, Kentucky, 40202, United States
Morgan Stanley Children's Hospital of New York Presbyterian
New York, New York, 10032, United States
Komansky Children's Hospital of New York Presbyterian
New York, New York, 10065, United States
Golisano Children's Hospital
Rochester, New York, 14642, United States
Duke University School of Medicine
Durham, North Carolina, 27710, United States
Children's Hospital of Richmond at VCU
Richmond, Virginia, 23219, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Schneider Children's Medical Center
Petah Tikva, 49504, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
No limitations or caveats to report.
Results Point of Contact
- Title
- Oliver Karam
- Organization
- Yale
Study Officials
- PRINCIPAL INVESTIGATOR
Oliver Karam, MD, PhD
Yale University
- PRINCIPAL INVESTIGATOR
Marianne Nellis, MD, MS
NewYork-Presbyterian / Weill Cornell
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Investigators and Outcome Assessors will be masked to the intervention, but the clinical team at the bedside will need to know the allocation to be able to prescribe platelet transfusion according to the randomized threshold.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2023
First Posted
April 3, 2023
Study Start
December 12, 2023
Primary Completion
January 2, 2025
Study Completion
March 25, 2025
Last Updated
May 31, 2025
Results First Posted
May 31, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- The investigators reserve the right to embargo the data for as long as two years after completion of the project (i.e. fall 2027) in order to allow the investigators' research team to publish additional observations from the data.
- Access Criteria
- The investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying the data after analyses are completed.
The proposed research will include data from 50 critically ill subjects who are on extracorporeal life support (ECMO) enrolled at ten participating sites. The final dataset will include demographic and medical information, as well as laboratory data. After the investigators' proposed research is complete, each participating site will destroy the key linking this data to protected health information (PHI). Thus, the data will then be completely de-identified. However, the investigators believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics, considering the variety of rare conditions leading to ECMO.