Clinical trial NCT04667468: Cold Stored Platelet in Hemorrhagic Shock
Official title: Cold Stored Platelet Early Intervention in Hemorrhagic Shock (CriSP-HS) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Trauma
Hemorrhage
Keywords: platelet
hemorrhagic shock
trauma
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2020-12-14
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: permuted block design
Primary purpose: TREATMENT

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.

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

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.

Primary outcomes:
measure: Study Feasibility
timeFrame: Enrollment through 30 days or discharge
Secondary outcomes:
measure: 24-hour Mortality
timeFrame: Enrollment through 24 hours
measure: 3-hour Mortality
timeFrame: Enrollment through 3 hours
measure: In Hospital Mortality
timeFrame: Enrollment through 30 days or discharge
measure: Hemorrhagic Death Alone
timeFrame: Enrollment through 24 hours
measure: Incidence of Acute Respiratory Distress Syndrome (ARDS)
timeFrame: Enrollment through 48 hours
measure: Incidence of Thromboembolic Events
timeFrame: Enrollment through 48 hours
measure: 30-day Mortality
timeFrame: Enrollment through 30 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Jackson
country: United States
facility: University of Mississippi
state: Mississippi
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: University of Texas Health Sciences Center Houston
state: Texas
Study officials:
affiliation: University of Pittsburgh
name: Jason Sperry, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Frank Guyette, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: