Cold Stored Platelet in Hemorrhagic Shock

NCT04667468 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: STUDY21100002W81XWH-16-D-0024
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 5

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.

Conditions

Trauma; Hemorrhage

Keywords

platelet; hemorrhagic shock; trauma

Outcome Measures

Primary Outcomes (1)

• Study Feasibility

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

  Enrollment through 30 days or discharge

Secondary Outcomes (7)

• 24-hour Mortality

  Enrollment through 24 hours

• 3-hour Mortality

  Enrollment through 3 hours

• In Hospital Mortality

  Enrollment through 30 days or discharge

• Hemorrhagic Death Alone

  Enrollment through 24 hours

• Incidence of Acute Respiratory Distress Syndrome (ARDS)

  Enrollment through 48 hours

Study Arms (2)

Cold-stored Platelet (CSP)

EXPERIMENTAL

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

Biological: Cold Stored Platelets (CSP)

Standard Care

ACTIVE COMPARATOR

resuscitation, blood and blood component transfusion per site standard care

Biological: Standard Care

Interventions

Cold Stored Platelets (CSP) BIOLOGICAL

early infusion of urgent release CSP

Cold-stored Platelet (CSP)

Standard Care BIOLOGICAL

standard care including blood and blood component therapy

Standard Care

Eligibility Criteria

• Age: 15 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Jason Sperry: lead
• United States Department of Defense: collaborator

Study Sites (5)

University of Southern California

Los Angeles, California, 90033, United States

Location

University of California San Francisco

San Francisco, California, 94110, United States

Location

University of Mississippi

Jackson, Mississippi, 39216, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Texas Health Sciences Center Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 38708880 DERIVED

MeSH Terms

Conditions

Wounds and Injuries; Hemorrhage; Shock, Hemorrhagic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Jason Sperry
• Organization: University of Pittsburgh

sperryjl@upmc.edu

412-215-7025

Study Officials

• Jason Sperry, MD, MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Frank Guyette, MD, MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: permuted block design

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 14, 2020
• Study Start: June 21, 2022
• Primary Completion: October 7, 2023
• Study Completion: November 20, 2023
• Last Updated: December 18, 2024
• Results First Posted: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will become available after publication of the primary manuscript.
• Access Criteria: Requests for data will be submitted in writing and reviewed by the Principal Investigator.

Locations

US (5)