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

Phase 4TerminatedNCT05293106

Weill Medical College of Cornell University9 enrolled

Overview

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).

This is a pilot clinical trial to assess the post-operative bleeding in children who receive pathogen-reduced (PR) platelet transfusions versus standard (large volume delayed sampling - LVDS) platelet transfusions both during and for 24 hours following cardiopulmonary bypass surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cardiopulmonary Bypass Surgery

Interventions

Platelet TransfusionBIOLOGICAL

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

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Morgan Stanley Children's Hospital at Columbia University

New York, New York, United States

Komansky Children's Hospital at Weill Cornell

New York, New York, United States

Outcomes

Primary Outcomes

Post-operative Bleeding Measured by Chest Tube Output for First 24 Hours Following Cardiopulmonary Bypass Surgery

Chest tube output for first 24 hours following cardiopulmonary bypass surgery

Time frame: Within the first 24 hours post-op.

Secondary Outcomes

Total Dose Red Blood Cell Volume Transfused in First 48 Hours Post-op

Total dose red blood cell volume transfused in first 48 hours post-op (includes both red blood cell as well as cellsaver)

Time frame: During hospitalization in the first 48 hours (no follow-up visits necessary)

Total Platelet Volume Transfused in the First 48 Hours Post-op

Total platelet volume transfused in the first 48 hours post-op

Time frame: During hospitalization in the first 48 hours (no follow-up visits necessary)

Total Plasma Volume Transfused in the First 48 Hours Post-op

Total plasma volume transfused in the first 48 hours post-op

Time frame: During hospitalization in the first 48 hours (no follow-up visits necessary)

Total Cryoprecipitate Volume Transfused in the First 48 Hours Post-op.

Total cryoprecipitate volume transfused in the first 48 hours post-op.

Time frame: During hospitalization in the first 48 hours (no follow-up visits necessary)

Data from ClinicalTrials.gov

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