CHIlled Platelet Study "CHIPS"

Summary

A phase 3 randomized partial blind storage duration ranging study in patients undergoing complex cardiac surgery that will compare the transfusion of cold stored platelets to standard room temperature stored platelets. The primary objective is to establish that cold stored platelets have a non-inferiority (or superiority) to room temperature platelets.

Conditions

• Acute Blood Loss

Interventions

BIOLOGICAL

Cold Stored Platelets

Platelets stored at 1-6 degree Celsius

BIOLOGICAL

Room Temperature Platelets

Platelets stored at 20-24 degrees Celsius

Sponsors & Collaborators

• University of Utah

  collaborator OTHER

• University of Minnesota

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• United States Department of Defense

  collaborator FED

• University of Pittsburgh

  collaborator OTHER

• Philip Spinella

  lead OTHER

Principal Investigators

• Philip C Spinella, MD · University of Pittsburgh

• Marie E Steiner, MD · University of Minnesota

• Nicole D Zantek, MD · University of Minnesota

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

SEQUENTIAL

Eligibility

Min Age

0 Days

Max Age

84 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-21

Primary Completion

2025-03-25

Completion

2025-04-21

FDA Drug

Yes

Countries

• United States
• Australia

Study Locations