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

NCT05293106 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 21-11024115
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

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).

Conditions

Cardiopulmonary Bypass Surgery

Keywords

Platelet Transfusion; LVDS platelet transfusion; PR platelet transfusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 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

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

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

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

Study Arms (3)

Pathogen-reduced (PR) platelet transfusions

ACTIVE COMPARATOR

FDA approved and already used in this patient population

Biological: Platelet Transfusion

Large volume delayed sampling - LVDS

ACTIVE COMPARATOR

FDA approved and already used in this patient population

Biological: Platelet Transfusion

No platelet transfusion

NO INTERVENTION

Subject will not receive a platelet transfusion

Interventions

Platelet Transfusion BIOLOGICAL

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

Large volume delayed sampling - LVDS; Pathogen-reduced (PR) platelet transfusions

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \>/=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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (2)

Morgan Stanley Children's Hospital at Columbia University

New York, New York, 10032, United States

Location

Komansky Children's Hospital at Weill Cornell

New York, New York, 10065, United States

Location

MeSH Terms

Interventions

Platelet Transfusion

Intervention Hierarchy (Ancestors)

Blood Component Transfusion; Blood Transfusion; Biological Therapy; Therapeutics

Limitations and Caveats

Due to difficulty in recruiting and enrolling subjects, only descriptive statistics were used to describe the 9 enrolled subjects.

Results Point of Contact

• Title: Marianne Nellis, MD
• Organization: Weill Cornell Medicine

man9026@med.cornell.edu

2127463056

Study Officials

• Marianne Nellis, MD, MS

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 24, 2022
• Study Start: July 5, 2022
• Primary Completion: September 17, 2023
• Study Completion: September 27, 2023
• Last Updated: August 20, 2024
• Results First Posted: August 20, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)