Last reviewed · How we verify
Cold Stored Platelet in Hemorrhagic Shock
Phase 2 trial testing Cold Stored Platelets (CSP) in Trauma in 200 participants. Completed in 20 November 2023.
| Lead sponsor | Jason Sperry |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 21 June 2022 |
| Primary completion | 7 October 2023 |
| Estimated completion | 20 November 2023 |
| Sites | 5 locations across United States |
Jason Sperry — full company profile →
Adults 15 to 90, any sex, with Trauma or Hemorrhage. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of eligible patients that can be randomized, enrolled, adhere to protocol, and completed follow-up
| Group | Value | 95% CI |
|---|---|---|
| Cold-stored Platelet (CSP) | 91 | |
| Standard Care | 82 |
Mortality within 24 hours
| Group | Value | 95% CI |
|---|---|---|
| Cold-stored Platelet (CSP) | 6 | |
| Standard Care | 10 |
Mortality within 3 hours
| Group | Value | 95% CI |
|---|---|---|
| Cold-stored Platelet (CSP) | 6 | |
| Standard Care | 7 |
mortality in-hospital
| Group | Value | 95% CI |
|---|---|---|
| Cold-stored Platelet (CSP) | 12 | |
| Standard Care | 13 |
mortality due to hemorrhage
| Group | Value | 95% CI |
|---|---|---|
| Cold-stored Platelet (CSP) | 6 | |
| Standard Care | 7 |
Berlin definition of mild ARDS will determine incidence and will be further stratified into Moderate and Severe
| Group | Value | 95% CI |
|---|---|---|
| Cold-stored Platelet (CSP) | 6 | |
| Standard Care | 3 |
Incidence of pulmonary embolism, venous thrombosis, or arterial thrombosis
| Group | Value | 95% CI |
|---|---|---|
| Cold-stored Platelet (CSP) | 10 | |
| Standard Care | 10 |
mortality within 30 days
| Group | Value | 95% CI |
|---|---|---|
| Cold-stored Platelet (CSP) | 12 | |
| Standard Care | 13 |
Time frame: 30 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Cold-stored Platelet (CSP) | Standard Care |
|---|---|---|---|
| Thromboembolic events | Vascular disorders | — | — |
| Coagulopathy | Blood and lymphatic system disorders | — | — |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | — | — |
| Transfusion Associated Cardiac Overload | Cardiac disorders | — | — |
Most-reported serious reactions: Thromboembolic events, Coagulopathy, Pneumonia, Transfusion Associated Cardiac Overload.
Data from ClinicalTrials.gov NCT04667468 adverse events section.
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.
3 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04667468.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing