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

Cardiopulmonary Bypass Surgery Clinical Trial

— PEDITREC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05293106
• Other study ID #: 21-11024115
• Status: Terminated
• Phase: Phase 4
• Start date: July 5, 2022
• Est. completion date: September 27, 2023

Study information

• Verified date: April 2024
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: September 27, 2023
• Est. primary completion date: September 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiopulmonary Bypass Surgery

Intervention

Biological:
• Platelet Transfusion
All platelet transfusions will be given as 10mL/kg as is considered standard of care.

Locations

Country	Name	City	State
United States	Komansky Children's Hospital at Weill Cornell	New York	New York
United States	Morgan Stanley Children's Hospital at Columbia University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative bleeding as 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	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	During hospitalization in the first 48 hours (no follow-up visits necessary)
Secondary	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)
Secondary	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)
Secondary	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)