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Blood Product

Cold-stored Platelet Transfusion for Traumatic Brain Injury (CriSP-TBI Trial)

Phase 2
Waitlist Available
Research Sponsored by Jason Sperry
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Need for platelet transfusion per standard practice
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after enrollment
Awards & highlights

CriSP-TBI Trial Summary

This trial is designed to determine the feasibility, efficacy, and safety of using urgent release cold stored platelets (CSP) to treat patients with TBI who require platelet transfusion. 100 patients will be enrolled and randomized to receive either standard care or early infusion of CSP. The primary outcome is feasibility, with the principal secondary clinical outcome being the 6-month Extended Glasgow Outcome Scale (GOS-E).

Who is the study for?
This trial is for adults with traumatic brain injury at risk of needing urgent neurosurgery, who may have used antiplatelet drugs before the injury or need a platelet transfusion. It's not for those under 18 or over 89, pregnant women, prisoners, people with penetrating injuries, hypotension in the ER, going to non-neurosurgical operations soon after arrival, or on certain anticoagulants.Check my eligibility
What is being tested?
The CriSP-TBI trial tests if giving cold stored platelets (CSP) quickly after a traumatic brain injury is feasible and safe compared to standard care. About 100 patients will be randomly chosen to receive either CSP early on or just the usual treatment without CSP.See study design
What are the potential side effects?
Potential side effects from receiving cold stored platelets could include reactions like fever and chills. There might also be risks related to bleeding complications since platelets are involved in blood clotting.

CriSP-TBI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I require platelet transfusions as per usual medical guidelines.

CriSP-TBI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Study feasibility
Secondary outcome measures
24-hour mortality
6-month Extended Glasgow Outcome Scale (GOS-E)
Galveston Orientation and Amnesia Test (GOAT)
+8 more

CriSP-TBI Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cold-stored Platelet (CSP)Experimental Treatment1 Intervention
early infusion of up to 2 units of urgent release cold stored platelets (CSP)
Group II: Standard careActive Control1 Intervention
standard care therapy

Find a Location

Who is running the clinical trial?

Jason SperryLead Sponsor
8 Previous Clinical Trials
6,785 Total Patients Enrolled
United States Department of DefenseFED
866 Previous Clinical Trials
327,405 Total Patients Enrolled
Jason L Sperry, MDStudy DirectorUniversity of Pittsburgh
2 Previous Clinical Trials
1,540 Total Patients Enrolled

Media Library

Cold Stored Platelets (Blood Product) Clinical Trial Eligibility Overview. Trial Name: NCT04726410 — Phase 2
Traumatic Brain Injury Research Study Groups: Cold-stored Platelet (CSP), Standard care
Traumatic Brain Injury Clinical Trial 2023: Cold Stored Platelets Highlights & Side Effects. Trial Name: NCT04726410 — Phase 2
Cold Stored Platelets (Blood Product) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04726410 — Phase 2

Frequently Asked Questions

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

How many people are chosen to participate in this research?

"The clinical trial is still recruiting participants, according to the information on clinicaltrials.gov. It was first posted on 3/21/2022 and most recently updated on 4/4/2022. They are enrolling 100 participants from 1 location."

Answered by AI

Is Cold Stored Platelets more likely to harm or help people?

"While Phase 2 trials don't have data supporting efficacy, there is some evidence that Cold Stored Platelets are safe. Therefore, we've given it a score of 2."

Answered by AI

What are the inclusionary criteria for this experiment?

"This study is for 100 individuals that have suffered a brain injury, with ages ranging from 18 to 89. Pre-injury use of antiplatelet medication is one key factor we are looking for in participants."

Answered by AI

Are we still able to enroll patients in this experiment?

"This information can be found on clinicaltrials.gov. To be eligible for the study, patients must meet the requirements which are posted online. The trial was originally advertised on March 21st, 2022 and updated April 4th, 2022."

Answered by AI

Are people of all ages being accepted for this clinical trial, or are only those 50 years and older eligible?

"In order to participate in this clinical trial, patients must be between 18-89 years old. However, there are 64 other trials for minors and 238 for adults over the age of 65."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Cold-stored Platelet Early Intervention in TBI
Jason Sperry 2022. "Cold-stored Platelet Early Intervention in TBI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04726410.
~32 spots leftby May 2025
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