Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cold Stored Platelet in Hemorrhagic Shock (CriSP-HS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04667468
Recruitment Status : Not yet recruiting
First Posted : December 14, 2020
Last Update Posted : January 15, 2021
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Jason Sperry, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Trauma Hemorrhage Biological: Cold Stored Platelets (CSP) Biological: Standard Care Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: permuted block design
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cold Stored Platelet Early Intervention in Hemorrhagic Shock (CriSP-HS) Trial
Estimated Study Start Date : June 1, 2021
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : August 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: Cold-stored Platelet (CSP)
early infusion of one apheresis unit urgent release cold stored platelets (CSP)
Biological: Cold Stored Platelets (CSP)
early infusion of urgent release CSP

Active Comparator: Standard Care
resuscitation, blood and blood component transfusion per site standard care
Biological: Standard Care
standard care including blood and blood component therapy




Primary Outcome Measures :
  1. Study feasibility [ Time Frame: Enrollment through 30 days or discharge ]
    proportion of eligible patients that can be randomized, enrolled, adhere to protocol, and complete follow-up


Secondary Outcome Measures :
  1. 24-hour mortality [ Time Frame: Enrollment through 24 hours ]
    Mortality within 24 hours

  2. 3-hour mortality [ Time Frame: Enrollment through 3 hours ]
    Mortality within 3 hours

  3. In hospital mortality [ Time Frame: Enrollment through 30 days or discharge ]
    mortality in-hospital

  4. Death from hemorrhage [ Time Frame: Enrollment through 24 hours ]
    mortality due to hemorrhage

  5. Blood or blood component type required for transfusion [ Time Frame: Enrollment through 24 hours ]
    Type of blood and/or blood components required to be transfused

  6. Amount of blood or blood component required for transfusion [ Time Frame: Enrollment through 24 hours ]
    number of units of blood and/or blood components required to be transfused

  7. Incidence of acute respiratory distress syndrome (ARDS) [ Time Frame: Enrollment through 48 hours ]
    Berlin definition of mild ARDS will determine incidence and will be further stratified into Moderate and Severe

  8. Time to hemostasis [ Time Frame: Enrollment through 4 hours ]
    Amount of time from randomization to point of nadir transfusion requirement of 1 unit of red blood cells in a 60-minute time period

  9. Incidence of coagulopathy by rapid thrombelastography (rTEG) [ Time Frame: Enrollment through 48 hours ]
    Coagulopathy as indicated by rTEG measures

  10. Incidence of allergic/transfusion reaction [ Time Frame: Enrollment through 24 hours ]
    Any transfusion complication in Emergency Department or Operating Room/Interventional Radiology

  11. Incidence of transfusion related acute lung injury (TRALI) [ Time Frame: Enrollment through 48 hours ]
    Occurrence of ARDS within 6 hours of transfusion of blood product

  12. rTEG measurement of platelet hemostatic function [ Time Frame: 60 minutes and 24 hours after arrival ]
    rTEG

  13. Prothrombin Time (PT) measurement of platelet hemostatic function [ Time Frame: 60 minutes and 24 hours after arrival ]
    PT

  14. International Normalized Ratio (INR) measurement of platelet hemostatic function [ Time Frame: 60 minutes and 24 hours after arrival ]
    INR

  15. Incidence of thromboembolic events [ Time Frame: Enrollment through 48 hours ]
    Incidence of pulmonary embolism, venous thrombosis, or arterial thrombosis

  16. 30-day mortality [ Time Frame: Enrollment through 30 days ]
    mortality within 30 days



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. 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

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04667468


Contacts
Layout table for location contacts
Contact: Jason Sperry, MD, MPH 412 802 8270 sperryjl@upmc.edu

Locations
Layout table for location information
United States, California
University of Southern California
Los Angeles, California, United States, 90033
Contact: Kenji Inaba, MD         
Principal Investigator: Kenji Inaba, MD         
University of California San Francisco
San Francisco, California, United States, 94110
Contact: Lucy Kornblith, MD         
Principal Investigator: Lucy Kornblith, MD         
United States, Mississippi
University of Mississippi
Jackson, Mississippi, United States, 39216
Contact: Matthew Kutcher, MD         
Principal Investigator: Matthew Kutcher, MD         
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Contact: Chad Wilson, MD, MPH         
Principal Investigator: Chad Wilson, MD, MPH         
University of Texas Health Sciences Center Houston
Houston, Texas, United States, 77030
Contact: Bryan Cotton, MD, MPH         
Principal Investigator: Bryan Cotton, MD, MPH         
Sponsors and Collaborators
Jason Sperry
United States Department of Defense
Investigators
Layout table for investigator information
Principal Investigator: Jason Sperry, MD, MPH University of Pittsburgh
Principal Investigator: Frank Guyette, MD, MPH University of Pittsburgh
Layout table for additonal information
Responsible Party: Jason Sperry, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04667468    
Other Study ID Numbers: PRO20040012
W81XWH-16-D-0024 ( Other Grant/Funding Number: Department of Defense )
First Posted: December 14, 2020    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data may be shared with the funding agency as well as other researchers upon request to the Principal Investigator.
Supporting Materials: Study Protocol
Informed Consent Form (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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jason Sperry, University of Pittsburgh:
platelet
hemorrhagic shock
trauma
Additional relevant MeSH terms:
Layout table for MeSH terms
Hemorrhage
Shock, Hemorrhagic
Pathologic Processes
Shock