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Platelet Transfusion

Cold vs Room Temperature Platelet Transfusions for Cardiac Surgery Patients (CHIPS Trial)

Phase 3

Recruiting

Research Sponsored by Philip Spinella

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Planned complex cardiac surgery with planned use of cardiopulmonary bypass

Age greater than 28 days and less than 85 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 and 72 hours from start time of first study platelet transfusion

Awards & highlights

CHIPS Trial Summary

This trial will compare the transfusion of cold stored platelets to standard room temperature stored platelets in patients undergoing complex cardiac surgery. The primary objective is to establish that cold stored platelets are at least as good as room temperature platelets.

Who is the study for?

The CHIPS trial is for patients aged between 28 days and less than 85 years who are scheduled for complex cardiac surgery with cardiopulmonary bypass. It's not suitable for those expecting to receive whole blood, have known platelet issues, are pregnant or previously in the study, among other specific health conditions.Check my eligibility

What is being tested?

This phase 3 trial compares cold stored platelets to standard room temperature stored ones in patients having complex heart surgery. The goal is to see if cold platelets work as well as or better than the standard treatment when transfused.See study design

What are the potential side effects?

While the side effects aren't specified here, generally, transfusion-related reactions can include fever, allergic reactions, and in rare cases more serious complications like difficulty breathing or infection.

CHIPS Trial 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 that will use a heart-lung machine.

Select...

I am older than 28 days and younger than 85 years.

CHIPS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 and 72 hours from start time of first study platelet transfusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 and 72 hours from start time of first study platelet transfusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 and 72 hours from start time of first study platelet transfusion for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Hemostatic efficacy

Secondary outcome measures

Chest tube output

Other outcome measures

All cause mortality

Arterial thrombotic event

Blood product administration

+11 more

CHIPS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cold Stored PlateletsExperimental Treatment1 Intervention

Platelets stored at 1-6 degree Celsius

Group II: Room Temperature PlateletsActive Control1 Intervention

Platelets stored at 20-24 degrees Celsius

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED

861 Previous Clinical Trials

226,194 Total Patients Enrolled

University of PittsburghOTHER

1,719 Previous Clinical Trials

16,341,341 Total Patients Enrolled

Philip SpinellaLead Sponsor

1 Previous Clinical Trials

1,000 Total Patients Enrolled

Media Library

Cold Stored Platelets (Platelet Transfusion) Clinical Trial Eligibility Overview. Trial Name: NCT04834414 — Phase 3

Acute Blood Loss Research Study Groups: Room Temperature Platelets, Cold Stored Platelets

Acute Blood Loss Clinical Trial 2023: Cold Stored Platelets Highlights & Side Effects. Trial Name: NCT04834414 — Phase 3

Cold Stored Platelets (Platelet Transfusion) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04834414 — Phase 3

Frequently Asked Questions

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

Is this study limited to a certain age group?

"For this particular trial, only those aged 29 days to 84 years qualify as participants. Out of the total 365 ongoing clinical trials, 57 are for those under 18 years old and 308 are for those over 65."

Answered by AI

Who is this clinical study meant for?

"This study is currently looking for 1000 individuals, aged between 29 days and 84 years old, who have acute coryza and meet the additional surgical requirements."

Answered by AI

How many study participants will be enrolled in total?

"In order to acquire the desired data, this clinical study needs to enroll 1000 willing and eligible patients. Luckily, there are many locations across the country that are participating in this trial, such as University of Michigan in Ann Arbor, Michigan and University of Florida in Gainesville, Florida."

Answered by AI

Do we have the green light from the FDA to use Cold Stored Platelets?

"Cold Stored Platelets have received a 3 for safety because this clinical trial is a Phase 3. That means there is available data that supports efficacy as well as multiple rounds of data that support safety."

Answered by AI

Could you inform me as to how many hospitals are participating in this research?

"There are a total of 17 sites where this study is being conducted. The locations are listed on the website and include Ann Arbor, Gainesville, and Dallas. Patients are encouraged to pick the site that is closest to them to reduce travel time and complications."

Answered by AI

Is this research study still enrolling new participants?

"As can be seen on clinicaltrials.gov, this research is still recruiting volunteers. The trial was first advertised on 2021-10-21 and the most recent update was on 2022-10-05."

Answered by AI