NCT05293106

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiopulmonary Bypass Surgery

Interventions

Type	Name	Description
BIOLOGICAL	Platelet Transfusion	All platelet transfusions will be given as 10mL/kg as is considered standard of care.

Timeline

• Start date: 2022-07-05
• Primary completion: 2023-09-17
• Completion: 2023-09-27
• First posted: 2022-03-24
• Last updated: 2024-08-20
• Results posted: 2024-08-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study