Cold Stored Platelet in Hemorrhagic Shock

NCT ID: NCT04667468

Last Updated: 2024-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-21
• Study Completion Date: 2023-11-20

Brief 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. 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.

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

Keywords

platelet; hemorrhagic shock; trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cold-stored Platelet (CSP)

early infusion of one apheresis unit urgent release cold stored platelets (CSP)

Group Type: EXPERIMENTAL

Cold Stored Platelets (CSP)

Intervention Type: BIOLOGICAL

early infusion of urgent release CSP

Standard Care

resuscitation, blood and blood component transfusion per site standard care

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: BIOLOGICAL

standard care including blood and blood component therapy

Interventions

Cold Stored Platelets (CSP)

early infusion of urgent release CSP

Intervention Type: BIOLOGICAL

Standard Care

standard care including blood and blood component therapy

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

Patients with traumatic injury who meet the following criteria:

1. Has 2 or more of any of the following:

1. Hypotension (systolic blood pressure ≤ 90 mmHg) in the prehospital or emergency department setting

2. Penetrating mechanism

3. 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

4. Heart rate ≥ 120 in the prehospital or emergency department setting

AND

2. Clinical team deems Operating Room (laparotomy, thoracotomy or vascular exploration) or Interventional Radiology for embolization within 60 minutes of arrival to be clinically indicated.

Exclusion Criteria

1. Wearing "NO CriSP" opt-out bracelet

2. Age >90 or <15 years of age

3. Isolated fall from standing injury mechanism

4. Prisoner

5. Pregnant

6. Traumatic arrest with >5 minutes of CPR without return of vital signs

7. Brain matter exposed or penetrating brain injury (gun shot wound [GSW])

8. Isolated drowning or hanging victims

9. Isolated burns > estimated 20% total body surface area

10. Objection to study voiced by subject or family member in Emergency Department

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Jason Sperry

OTHER

Sponsor Role: lead

Responsible Party

Jason Sperry

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jason Sperry, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Frank Guyette, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Southern California

Los Angeles, California, United States

University of California San Francisco

San Francisco, California, United States

University of Mississippi

Jackson, Mississippi, United States

Baylor College of Medicine

Houston, Texas, United States

University of Texas Health Sciences Center Houston

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38708880 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

W81XWH-16-D-0024

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY21100002

Identifier Type: -

Identifier Source: org_study_id