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Extended Cold Stored Apheresis Platelets in Cardiac Surgery Patients

NCT05220787 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-07-27

No results posted yet for this study

Summary

This trial is being performed to evaluate the feasibility of the study protocol and to test the efficacy and safety of platelets stored at cold conditions (1-6°C) in 100% plasma for 10-14 days (CSP) in cardiac surgery patients who are actively bleeding and require platelet transfusion.

Conditions

Interventions

BIOLOGICAL

Cold stored platelets in 100% plasma stored for 10-14 days

Subjects will receive cold stored platelets from the start of surgery until 24 hours after the end of surgery

BIOLOGICAL

Room temperature stored platelets in 100% plasma stored for up to 7 days

Subjects will receive room temperature stored platelets from the start of surgery until 24 hours after the end of surgery

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Moritz Stolla, MD

    lead OTHER

Principal Investigators

  • Moritz Stolla, MD · Bloodworks Northwest

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-21
Primary Completion
2024-10-29
Completion
2024-10-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05220787 on ClinicalTrials.gov