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

Phase 4

Terminated

• Conditions: Cardiopulmonary Bypass Surgery
• Interventions: Biological: Platelet Transfusion

• Registration Number: NCT05293106
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

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).

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 Timeline

• Study First Submitted: 2022-03-14
• Study First Submitted QC: 2022-03-14
• Study First Posted: 2022-03-24
• Study Start: 2022-07-05
• Primary Completion: 2023-09-17
• Study Completion: 2023-09-27
• Results First Submitted: 2024-06-17
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-30
• Last Update Submitted: 2024-07-30
• Results First Posted: 2024-08-20
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pathogen-reduced (PR) platelet transfusions	Platelet Transfusion	FDA approved and already used in this patient population
Large volume delayed sampling - LVDS	Platelet Transfusion	FDA approved and already used in this patient population

Primary Outcome Measures

Name	Time	Method
Post-operative Bleeding Measured by Chest Tube Output for First 24 Hours Following Cardiopulmonary Bypass Surgery	Within the first 24 hours post-op.	Chest tube output for first 24 hours following cardiopulmonary bypass surgery

Secondary Outcome Measures

Name	Time	Method
Total Platelet Volume Transfused in the First 48 Hours Post-op	During hospitalization in the first 48 hours (no follow-up visits necessary)	Total platelet volume transfused in the first 48 hours post-op
Total Dose Red Blood Cell Volume Transfused in First 48 Hours Post-op	During hospitalization in the first 48 hours (no follow-up visits necessary)	Total dose red blood cell volume transfused in first 48 hours post-op (includes both red blood cell as well as cellsaver)
Total Plasma 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 Cryoprecipitate 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.

Trial Locations

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