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Cold Stored Platelet in Hemorrhagic Shock (CriSP-HS)

Primary Purpose

Trauma, Hemorrhage

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cold Stored Platelets (CSP)
Standard Care
Sponsored by
Jason Sperry
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma focused on measuring platelet, hemorrhagic shock, trauma

Eligibility Criteria

15 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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.

Sites / Locations

  • University of Southern California
  • University of California San Francisco
  • University of Mississippi
  • Baylor College of Medicine
  • University of Texas Health Sciences Center Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cold-stored Platelet (CSP)

Standard Care

Arm Description

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

resuscitation, blood and blood component transfusion per site standard care

Outcomes

Primary Outcome Measures

Study feasibility
proportion of eligible patients that can be randomized, enrolled, adhere to protocol, and complete follow-up

Secondary Outcome Measures

24-hour mortality
Mortality within 24 hours
3-hour mortality
Mortality within 3 hours
In hospital mortality
mortality in-hospital
Death from hemorrhage
mortality due to hemorrhage
Blood or blood component type required for transfusion
Type of blood and/or blood components required to be transfused
Amount of blood or blood component required for transfusion
number of units of blood and/or blood components required to be transfused
Incidence of acute respiratory distress syndrome (ARDS)
Berlin definition of mild ARDS will determine incidence and will be further stratified into Moderate and Severe
Time to hemostasis
Amount of time from randomization to point of nadir transfusion requirement of 1 unit of red blood cells in a 60-minute time period
Incidence of coagulopathy by rapid thrombelastography (rTEG)
Coagulopathy as indicated by rTEG measures
Incidence of allergic/transfusion reaction
Any transfusion complication in Emergency Department or Operating Room/Interventional Radiology
Incidence of transfusion related acute lung injury (TRALI)
Occurrence of ARDS within 6 hours of transfusion of blood product
rTEG measurement of platelet hemostatic function
rTEG
Prothrombin Time (PT) measurement of platelet hemostatic function
PT
International Normalized Ratio (INR) measurement of platelet hemostatic function
INR
Incidence of thromboembolic events
Incidence of pulmonary embolism, venous thrombosis, or arterial thrombosis
30-day mortality
mortality within 30 days

Full Information

First Posted
November 24, 2020
Last Updated
October 19, 2023
Sponsor
Jason Sperry
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT04667468
Brief Title
Cold Stored Platelet in Hemorrhagic Shock
Acronym
CriSP-HS
Official Title
Cold Stored Platelet Early Intervention in Hemorrhagic Shock (CriSP-HS) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 21, 2022 (Actual)
Primary Completion Date
October 7, 2023 (Actual)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jason Sperry
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Hemorrhage
Keywords
platelet, hemorrhagic shock, trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
permuted block design
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cold-stored Platelet (CSP)
Arm Type
Experimental
Arm Description
early infusion of one apheresis unit urgent release cold stored platelets (CSP)
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
resuscitation, blood and blood component transfusion per site standard care
Intervention Type
Biological
Intervention Name(s)
Cold Stored Platelets (CSP)
Intervention Description
early infusion of urgent release CSP
Intervention Type
Biological
Intervention Name(s)
Standard Care
Intervention Description
standard care including blood and blood component therapy
Primary Outcome Measure Information:
Title
Study feasibility
Description
proportion of eligible patients that can be randomized, enrolled, adhere to protocol, and complete follow-up
Time Frame
Enrollment through 30 days or discharge
Secondary Outcome Measure Information:
Title
24-hour mortality
Description
Mortality within 24 hours
Time Frame
Enrollment through 24 hours
Title
3-hour mortality
Description
Mortality within 3 hours
Time Frame
Enrollment through 3 hours
Title
In hospital mortality
Description
mortality in-hospital
Time Frame
Enrollment through 30 days or discharge
Title
Death from hemorrhage
Description
mortality due to hemorrhage
Time Frame
Enrollment through 24 hours
Title
Blood or blood component type required for transfusion
Description
Type of blood and/or blood components required to be transfused
Time Frame
Enrollment through 24 hours
Title
Amount of blood or blood component required for transfusion
Description
number of units of blood and/or blood components required to be transfused
Time Frame
Enrollment through 24 hours
Title
Incidence of acute respiratory distress syndrome (ARDS)
Description
Berlin definition of mild ARDS will determine incidence and will be further stratified into Moderate and Severe
Time Frame
Enrollment through 48 hours
Title
Time to hemostasis
Description
Amount of time from randomization to point of nadir transfusion requirement of 1 unit of red blood cells in a 60-minute time period
Time Frame
Enrollment through 4 hours
Title
Incidence of coagulopathy by rapid thrombelastography (rTEG)
Description
Coagulopathy as indicated by rTEG measures
Time Frame
Enrollment through 48 hours
Title
Incidence of allergic/transfusion reaction
Description
Any transfusion complication in Emergency Department or Operating Room/Interventional Radiology
Time Frame
Enrollment through 24 hours
Title
Incidence of transfusion related acute lung injury (TRALI)
Description
Occurrence of ARDS within 6 hours of transfusion of blood product
Time Frame
Enrollment through 48 hours
Title
rTEG measurement of platelet hemostatic function
Description
rTEG
Time Frame
60 minutes and 24 hours after arrival
Title
Prothrombin Time (PT) measurement of platelet hemostatic function
Description
PT
Time Frame
60 minutes and 24 hours after arrival
Title
International Normalized Ratio (INR) measurement of platelet hemostatic function
Description
INR
Time Frame
60 minutes and 24 hours after arrival
Title
Incidence of thromboembolic events
Description
Incidence of pulmonary embolism, venous thrombosis, or arterial thrombosis
Time Frame
Enrollment through 48 hours
Title
30-day mortality
Description
mortality within 30 days
Time Frame
Enrollment through 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Sperry, MD, MPH
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frank Guyette, MD, MPH
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
University of Mississippi
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Sciences Center Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data may be shared with the funding agency as well as other researchers upon request to the Principal Investigator.
IPD Sharing Time Frame
Data will become available after publication of the primary manuscript.
IPD Sharing Access Criteria
Requests for data will be submitted in writing and reviewed by the Principal Investigator.

Learn more about this trial

Cold Stored Platelet in Hemorrhagic Shock

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