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

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).

Study Overview

• Status: Terminated
• Conditions: Cardiopulmonary Bypass Surgery
• Intervention / Treatment: Biological: Platelet Transfusion

Detailed Description

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
• Enrollment (Actual): 9
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Morgan Stanley Children's Hospital at Columbia University
    • New York, New York, United States, 10065
      • Komansky Children's Hospital at Weill Cornell

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pathogen-reduced (PR) platelet transfusions; FDA approved and already used in this patient population	Biological: Platelet Transfusion; All platelet transfusions will be given as 10mL/kg as is considered standard of care.
Active Comparator: Large volume delayed sampling - LVDS; FDA approved and already used in this patient population	Biological: Platelet Transfusion; All platelet transfusions will be given as 10mL/kg as is considered standard of care.
No Intervention: No platelet transfusion; Subject will not receive a platelet transfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Within the first 24 hours post-op.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	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	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.	During hospitalization in the first 48 hours (no follow-up visits necessary)

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Marianne Nellis, MD, MS, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2022
• Primary Completion (Actual): September 17, 2023
• Study Completion (Actual): September 27, 2023

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (Actual): March 24, 2022

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Platelet Transfusion; LVDS platelet transfusion; PR platelet transfusion
• Other Study ID Numbers: 21-11024115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No