Cold Stored Platelet in Hemorrhagic Shock
Trauma · Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT04667468 ↗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
| Outcome | Result | p-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
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.
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.