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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-op through day 28.

Awards & highlights

CHASE Trial 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.Check my eligibility

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.See study design

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.

CHASE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a complex heart surgery involving multiple valves or the aorta with cardiopulmonary bypass.

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I am 18 years old or older.

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I weigh more than 40 kg.

CHASE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-op through day 28.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of the recruitment and accrual into the study protocol.

Secondary outcome measures

Chest tube output volume

Hemostatic agents administered

Hospital free days

+8 more

CHASE 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Moritz Stolla, MDLead Sponsor

United States Department of DefenseFED

865 Previous Clinical Trials

327,669 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to contribute to this research project?

"This trial is looking to recruit 30 individuals of legal age, who weigh more than 40 kg and require cardiac surgery with bypass. Participants must be able to comprehend the Informed Consent Form (ICF), converse in English, and not participate in any other interventions during the study period. Furthermore, if participants are female of childbearing potential they need a negative pregnancy test and agree to use one of several contraceptive methods for duration of participation. Finally, it's important that all clinical sites can obtain both possible platelet products needed per protocol given the subject's planned date for surgery."

Answered by AI

Are there any unoccupied slots for prospective participants in this trial?

"The clinicaltrial.gov website states that this medical trial is no longer actively recruiting patients, having first posted on February 1st and last updated on January 21st of 2022. However, there are numerous other trials currently looking for volunteers with 389 options available as of right now."

Answered by AI