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Phase 2 N=200 Randomized Single-blind Treatment

Cold Stored Platelet in Hemorrhagic Shock

Trauma · Hemorrhage

Enrolled (actual)
200
Serious AEs
6.5%
Results posted
Dec 2024
Primary outcome: Primary: Study Feasibility — 91; 82 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Cold Stored Platelets (CSP) (Biological); Standard Care (Biological)
Age
Pediatric, Adult, Older Adult · 15+ yrs
Sex
All
Sponsor
Jason Sperry
Primary completion
Oct 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Study Feasibility
91; 82
SECONDARY
24-hour Mortality
6; 10
SECONDARY
3-hour Mortality
6; 7
SECONDARY
In Hospital Mortality
12; 13
SECONDARY
Hemorrhagic Death Alone
6; 7
SECONDARY
Incidence of Acute Respiratory Distress Syndrome (ARDS)
6; 3
SECONDARY
Incidence of Thromboembolic Events
10; 10
SECONDARY
30-day Mortality
12; 13

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.

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04667468). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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