← Back to Search

Platelet Transfusion

Extended Cold Stored Platelets for Blood Loss in Cardiac Surgery (CHASE Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Moritz Stolla, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is scheduled for redo, triple valve, or complex aortic cardiac surgery with cardiopulmonary bypass
Subject age is greater than or equal to 18 years of age
Must not have
Subject refuses blood products
Subject has active infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-op through day 28.
Awards & highlights

Summary

This trial is testing how well platelets stored at cold conditions work in cardiac surgery patients who are actively bleeding and need a platelet transfusion.

Who is the study for?
Adults over 18, who can speak/read English and weigh more than 40 kg, scheduled for complex cardiac surgery with bypass. They must understand/sign the consent form, not be in other studies, and use contraception if applicable. Excluded are those with severe transfusion reactions, certain medical conditions or treatments post-surgery, thrombocytopenia, pregnancy/breastfeeding status, prisoners, active infections or history of unprovoked blood clots.
What is being tested?
The trial is testing the safety and effectiveness of cold-stored platelets (1-6°C) kept for 10-14 days versus room temperature stored platelets kept up to 7 days in patients undergoing cardiac surgery who need a platelet transfusion due to active bleeding.
What are the potential side effects?
Potential side effects may include reactions related to the transfusion process such as fever or allergic responses. There's also a risk of bleeding complications or clotting issues due to the condition of the stored platelets.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a complex heart surgery involving multiple valves or the aorta with cardiopulmonary bypass.
Select...
I am 18 years old or older.
Select...
I weigh more than 40 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I refuse to receive blood transfusions.
Select...
I currently have an active infection.
Select...
I have had a blood clot in my leg or lung without an obvious cause.
Select...
I have a known bleeding disorder.
Select...
I am scheduled to receive a blood transfusion from my own blood or a directed donor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-op through day 28.
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-op through day 28. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of the recruitment and accrual into the study protocol.
Secondary study objectives
Chest tube output volume
Hemostatic agents administered
Hospital free days
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cold stored platelets in 100% plasma stored for 10-14 daysExperimental Treatment1 Intervention
Cold stored apheresis platelets in 100% plasma stored for 10-14 days, maximum of up to three units (3x10\^11/unit) from the start of surgery until 24 hours after the end of surgery
Group II: Room temperature stored platelets in 100% plasma stored for up to 7 daysActive Control1 Intervention
Room temperature stored platelets in 100% plasma stored for up to 7 days, maximum of up to three units (3x10\^11/unit) from the start of surgery until 24 hours after the end of surgery

Find a Location

Who is running the clinical trial?

Moritz Stolla, MDLead Sponsor
United States Department of DefenseFED
891 Previous Clinical Trials
332,448 Total Patients Enrolled

Media Library

Cold stored platelets in 100% plasma stored for 10-14 days (Platelet Transfusion) Clinical Trial Eligibility Overview. Trial Name: NCT05220787 — Phase 1 & 2
Blood Loss Research Study Groups: Room temperature stored platelets in 100% plasma stored for up to 7 days, Cold stored platelets in 100% plasma stored for 10-14 days
Blood Loss Clinical Trial 2023: Cold stored platelets in 100% plasma stored for 10-14 days Highlights & Side Effects. Trial Name: NCT05220787 — Phase 1 & 2
Cold stored platelets in 100% plasma stored for 10-14 days (Platelet Transfusion) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05220787 — Phase 1 & 2
~1 spots leftby Oct 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top