Clinical trial

Assessing the Hemostatic Efficacy of Pathogen Reduced Platelets in Children Undergoing Cardiopulmonary Bypass Surgery: A Pilot Clinical Trial

Name

21-11024115

Description

This study is testing whether pathogen reduced platelets can control bleeding as well as non-pathogen reduced platelets (otherwise known as large volume delayed sampling).

Trial arms

Trial start

2022-07-05

Estimated PCD

2023-09-17

Trial end

2023-09-27

Status

Terminated

Phase

Early phase I

Treatment

Platelet Transfusion

All platelet transfusions will be given as 10mL/kg as is considered standard of care.

Arms:

Large volume delayed sampling - LVDS, Pathogen-reduced (PR) platelet transfusions

Size

Primary endpoint

Post-operative bleeding as measured by chest tube output for first 24 hours following cardiopulmonary bypass surgery

Within the first 24 hours post-op.

Eligibility criteria

Inclusion Criteria: * Male or female 0 up to and including 18 years of age * Undergoing elective cardiopulmonary bypass surgery * Are planned to have a chest tube placed in the operating room prior to chest closure Exclusion Criteria: * \>/=19 years of age * Preterm infants (less than 38-week gestational age at time of surgery) * On extracorporeal membrane oxygenation (ECMO) or ventricular assist device prior to surgery * Family requests limitation of blood products (i.e. Jehovah's Witness) * Congenital bleeding disorder * Are planned to require ECMO post-op * Previously enrolled in the study

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 9, 'type': 'ACTUAL'}}

Updated at

2024-04-18

1 organization

1 product

1 indication

Organization

Weill Medical College of Cornell University

Product

Platelet Transfusion

Indication

Cardiopulmonary Bypass Surgery