ECMO Hemostatic Transfusions in Children

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.

Conditions

• Extracorporeal Membrane Oxygenation Complication
• Hemorrhage
• Thromboembolism
• Transfusion Adverse Reaction

Interventions

BIOLOGICAL

Platelet Transfusion

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.

Sponsors & Collaborators

• Weill Medical College of Cornell University

  collaborator OTHER

• University of Utah

  collaborator OTHER

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Columbia University

  collaborator OTHER

• Virginia Commonwealth University

  collaborator OTHER

• University of Rochester

  collaborator OTHER

• Children's Hospital and Health System Foundation, Wisconsin

  collaborator OTHER

• Duke University

  collaborator OTHER

• Johns Hopkins All Children's Hospital

  collaborator OTHER

• University of Iowa

  collaborator OTHER

• Emory University

  collaborator OTHER

• Schneider Medical Children's Center, Israel

  collaborator UNKNOWN

• Yale University

  lead OTHER

Principal Investigators

• Oliver Karam, MD, PhD · Yale University

• Marianne Nellis, MD, MS · NewYork-Presbyterian / Weill Cornell

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-12

Primary Completion

2025-01-02

Completion

2025-03-25

Countries

• United States
• Israel

Study Locations