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TraumaPhase 2CriSP-HSNCT04667468

Cold Stored Platelet in Hemorrhagic Shock

A Phase 2 study testing Cold Stored Platelets (CSP) in people with Trauma and Hemorrhage, run by Jason Sperry at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Cold Stored Platelet Early Intervention in Hemorrhagic Shock (CriSP-HS) trial is a proposed 3 year, open label, multi-center, randomized trial designed to determine the feasibility, efficacy, and safety of urgent release cold stored platelets (CSP) in patients in hemorrhagic shock. Read more about this study

Who is it for?
Ages 15 to 90 years
Conditions the study is for
Trauma, Hemorrhage
What is being tested?
Cold Stored Platelets (CSP)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
5 sitesUnited States
Study dates
21 Jun 2022to 20 Nov 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 90 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients with traumatic injury who meet the following criteria:
  • Has 2 or more of any of the following:
  • Hypotension (systolic blood pressure ≤ 90 mmHg) in the prehospital or emergency department setting
  • Penetrating mechanism
  • Abdominal or Extended Focused Assessment with Sonography for Trauma (FAST) abdominal ultrasound is positive or equivocal or deferred by clinical team due to emergent visit to Interventional Radiology or a need for emergent laparotomy, thoracotomy, or vascular exploration
  • Heart rate ≥ 120 in the prehospital or emergency department setting
  • AND
  • Clinical team deems Operating Room (laparotomy, thoracotomy or vascular exploration) or Interventional Radiology for embolization within 60 minutes of arrival to be clinically indicated.

Who cannot join

  • Wearing "NO CriSP" opt-out bracelet
  • Age >90 or <15 years of age
  • Isolated fall from standing injury mechanism
  • Prisoner
  • Pregnant
  • Traumatic arrest with >5 minutes of CPR without return of vital signs
Show all 12Show fewer
  • Brain matter exposed or penetrating brain injury (gun shot wound [GSW])
  • Isolated drowning or hanging victims
  • Isolated burns > estimated 20% total body surface area
  • Objection to study voiced by subject or family member in Emergency Department
  • Inclusion and exclusion criteria will be assessed based on information available at the time of enrollment. If, after subsequent review, it is determined that the subject did not meet inclusion criteria and/or met exclusion criteria, the subject will remain enrolled in the study based on the intent-to-treat principle.
  • If a verbal report must be used in lieu of physical documentation or directly witnessing inclusion criteria, documentation of the verbal report will serve as the source documentation for determining eligibility.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Texas Health Sciences Center Houston

    Houston, Texas, 77030

  • University of Mississippi

    Jackson, Mississippi, 39216

  • University of Southern California

    Los Angeles, California, 90033

  • University of California San Francisco

    San Francisco, California, 94110

Other trials in United States

About this study

Official title: Cold Stored Platelet Early Intervention in Hemorrhagic Shock (CriSP-HS) Trial

The Cold Stored Platelet Early Intervention in Hemorrhagic Shock (CriSP-HS) trial is a proposed 3 year, open label, multi-center, randomized trial designed to determine the feasibility, efficacy, and safety of urgent release cold stored platelets (CSP) in patients in hemorrhagic shock. Patients will be randomized to receive either standard care or early infusion of urgent release cold stored platelets (CSP). The proposed pilot study will utilize 5 level-1 trauma centers from within the LITES network and will enroll approximately 200 patients. The primary outcome for the pilot trial is feasibility, with principal secondary clinical outcome of 24 hour mortality.

Read the detailed description

The acute management of the severely injured patient with hemorrhage following trauma center arrival has evolved over the last decade.

Current treatment priorities include prevention of coagulopathy through minimization of crystalloid and early blood component resuscitation including plasma and platelets in equal ratios with packed red blood cells. These in-hospital practices, termed damage control resuscitation, are widely used in both battlefield and civilian resuscitation following traumatic injury.

Initiation of the tenets of damage control resuscitation early, soon after arrival, has the potential to reduce downstream complications attributable to hemorrhage by intervening closer to the time of injury, prior to the development of coagulopathy; irreversible shock; and the ensuing inflammatory response. Other blood constituents have recently been shown to be beneficial when given early. Thawed plasma transfusion has been shown to safely reduce 30-day mortality when infused early, in the prehospital setting, in patients at risk of hemorrhagic shock and this separation of survival occurs within the first 3 hours. Platelet transfusion is associated with improved outcomes in the acutely bleeding patients. Cold Stored Platelets have been reported to reduce blood loss when provided for hemorrhage and are a more effective hemostatic product.

Cold stored platelets are less likely to become bacterial contaminated and were the standard of care platelet product until the 1980s. Despite this history and potential benefits, the risks associated with urgent release cold stored platelets and their respective efficacy and function over time are not known in patients with hemorrhagic shock.

By providing Cold Stored Platelets in an urgent release fashion following injury, a potentially superior hemostatic agent is given early, closer to the time of injury. The current pilot trial was designed to determine the feasibility, efficacy and safety of urgent release cold stored platelets as compared to standard care in injured patients in hemorrhagic shock. There are no high-level data which appropriately characterize the urgent release use of cold stored platelets out to 14 days or their function over that time period as compared to standard room temperature platelets. These results will be able to inform future large randomized clinical trials allowing the most appropriate injured population, inclusion criteria, and primary outcome to be selected and utilized.

Conditions
Trauma, Hemorrhage
Being tested
Cold Stored Platelets (CSP), Standard Care
Keywords
platelet, hemorrhagic shock, trauma
Medical subject headings
Wounds and Injuries, Hemorrhage, Shock, Hemorrhagic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cold Stored Platelets (CSP)Biological

    early infusion of urgent release CSP

  • Standard CareBiological

    standard care including blood and blood component therapy

Study groups in NCT04667468
Study groupRoleWhat they receive
Cold-stored Platelet (CSP)Experimentalearly infusion of one apheresis unit urgent release cold stored platelets (CSP)
Receives: Biological: Cold Stored Platelets (CSP)
Standard CareActive comparatorresuscitation, blood and blood component transfusion per site standard care
Receives: Biological: Standard Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Study Feasibility

    Proportion of eligible patients that can be randomized, enrolled, adhere to protocol, and completed follow-up

    Measured: Enrollment through 30 days or discharge

Secondary outcomes (7)

  1. 24-hour Mortality

    Mortality within 24 hours

    Measured: Enrollment through 24 hours

  2. 3-hour Mortality

    Mortality within 3 hours

    Measured: Enrollment through 3 hours

  3. In Hospital Mortality

    mortality in-hospital

    Measured: Enrollment through 30 days or discharge

  4. Hemorrhagic Death Alone

    mortality due to hemorrhage

    Measured: Enrollment through 24 hours

  5. Incidence of Acute Respiratory Distress Syndrome (ARDS)

    Berlin definition of mild ARDS will determine incidence and will be further stratified into Moderate and Severe

    Measured: Enrollment through 48 hours

  6. Incidence of Thromboembolic Events

    Incidence of pulmonary embolism, venous thrombosis, or arterial thrombosis

    Measured: Enrollment through 48 hours

  7. 30-day Mortality

    mortality within 30 days

    Measured: Enrollment through 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2020
  2. Study start21 Jun 2022
  3. Primary completion7 Oct 2023
  4. Study completion20 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
permuted block design
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04667468
Sponsor's protocol ID
STUDY21100002
Other IDs
W81XWH-16-D-0024
Acronym
CriSP-HS
Status last verified
Dec 2024
First submitted
24 Nov 2020
Last updated
18 Dec 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified data may be shared with the funding agency as well as other researchers upon request to the Principal Investigator.

Publications

  • Sperry JL, Guyette FX, Rosario-Rivera BL, Kutcher ME, Kornblith LZ, Cotton BA, Wilson CT, Inaba K, Zadorozny EV, Vincent LE, Harner AM, Love ET, Doherty JE, Cuschieri J, Kornblith AE, Fox EE, Bai Y, Hoffman MK, Seger CP, Hudgins J, Mallett-Smith S, Neal MD, Leeper CM, Spinella PC, Yazer MH, Wisniewski SR; Cold Stored Platelet for Hemorrhagic Shock (CRISP-HS) Study Group. Early Cold Stored Platelet Transfusion Following Severe Injury: A Randomized Clinical Trial. Ann Surg. 2024 Aug 1;280(2):212-221. doi: 10.1097/SLA.0000000000006317. Epub 2024 May 6.

    PubMed 38708880

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cold Stored Platelets (CSP) in people with Trauma and Hemorrhage, run by Jason Sperry at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Study Feasibility (time frame: Enrollment through 30 days or discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04667468, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.

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