A Phase 2 interventional study of Cold Stored Platelets (CSP) and Standard Care in Trauma and Hemorrhage, sponsored by Jason Sperry. Completed at 5 sites in United States. Open to participants aged 15 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-12-18.
Sponsored by Jason Sperry · Phase 2, Interventional, and Treatment
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.
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.
2,217 studies on the registry are indexed under Wounds and Injuries; 441 are open to participants now.
This study's enrollment of 200 is above the median of 70 across 1,424 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Jason Sperry is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with traumatic injury who meet the following criteria:
Has 2 or more of any of the following:
AND
Exclusion Criteria:
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.
early infusion of one apheresis unit urgent release cold stored platelets (CSP)
Biological: Cold Stored Platelets (CSP)
resuscitation, blood and blood component transfusion per site standard care
Biological: Standard Care
early infusion of urgent release CSP
standard care including blood and blood component therapy
Study Feasibility
Proportion of eligible patients that can be randomized, enrolled, adhere to protocol, and completed follow-up
Time frame: Enrollment through 30 days or discharge
24-hour Mortality
Mortality within 24 hours
Time frame: Enrollment through 24 hours
3-hour Mortality
Mortality within 3 hours
Time frame: Enrollment through 3 hours
In Hospital Mortality
mortality in-hospital
Time frame: Enrollment through 30 days or discharge
Hemorrhagic Death Alone
mortality due to hemorrhage
Time frame: Enrollment through 24 hours
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 frame: Enrollment through 48 hours
Incidence of Thromboembolic Events
Incidence of pulmonary embolism, venous thrombosis, or arterial thrombosis
Time frame: Enrollment through 48 hours
30-day Mortality
mortality within 30 days
Time frame: Enrollment through 30 days
| Milestone | Cold-stored Platelet (CSP) | Standard Care |
|---|---|---|
| Started | 102 | 98 |
| Completed | 102 | 98 |
| Not completed | 0 | 0 |
Proportion of eligible patients that can be randomized, enrolled, adhere to protocol, and completed follow-up
| Participants | Cold-stored Platelet (CSP) | Standard Care |
|---|---|---|
| Study Feasibility | 91 | 82 |
Mortality within 24 hours
| Participants | Cold-stored Platelet (CSP) | Standard Care |
|---|---|---|
| 24-hour Mortality | 6 | 10 |
Mortality within 3 hours
| Participants | Cold-stored Platelet (CSP) | Standard Care |
|---|---|---|
| 3-hour Mortality | 6 | 7 |
mortality in-hospital
| Participants | Cold-stored Platelet (CSP) | Standard Care |
|---|---|---|
| In Hospital Mortality | 12 | 13 |
mortality due to hemorrhage
| Participants | Cold-stored Platelet (CSP) | Standard Care |
|---|---|---|
| Hemorrhagic Death Alone | 6 | 7 |
Berlin definition of mild ARDS will determine incidence and will be further stratified into Moderate and Severe
| Participants | Cold-stored Platelet (CSP) | Standard Care |
|---|---|---|
| Incidence of Acute Respiratory Distress Syndrome (ARDS) | 6 | 3 |
Incidence of pulmonary embolism, venous thrombosis, or arterial thrombosis
| Participants | Cold-stored Platelet (CSP) | Standard Care |
|---|---|---|
| Incidence of Thromboembolic Events | 10 | 10 |
mortality within 30 days
| Participants | Cold-stored Platelet (CSP) | Standard Care |
|---|---|---|
| 30-day Mortality | 12 | 13 |
Collected over 30 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cold-stored Platelet (CSP) | 12/102 (11.8%) | 9/102 (8.8%) | 0/102 (0%) |
| Standard Care | 13/98 (13.3%) | 4/98 (4.1%) | 0/98 (0%) |
| Event | Cold-stored Platelet (CSP) | Standard Care |
|---|---|---|
| Thromboembolic eventsVascular disorders | 6/102 | 3/98 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 1/102 | 1/98 |
| CoagulopathyBlood and lymphatic system disorders | 1/102 | 0/98 |
| Transfusion Associated Cardiac OverloadCardiac disorders | 1/102 | 0/98 |
| Age, Continuous(years) | Cold-stored Platelet (CSP) | Standard Care | Total |
|---|---|---|---|
| Mean | 35.3 ± 14.4 | 34.4 ± 13.5 | 34.8 ± 13.9 |
| Sex: Female, Male(Participants) | Cold-stored Platelet (CSP) | Standard Care | Total |
|---|---|---|---|
| Female | 17 | 20 | 37 |
| Male | 85 | 78 | 163 |
| Race/Ethnicity, Customized(Participants) | Cold-stored Platelet (CSP) | Standard Care | Total |
|---|---|---|---|
| Caucasian | 28 | 18 | 46 |
| Black | 47 | 51 | 98 |
| Hispanic | 20 | 13 | 33 |
| Other including Asian and unknown | 13 | 13 | 26 |
| Missing | 0 | 3 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified data may be shared with the funding agency as well as other researchers upon request to the Principal Investigator.
Supporting information: Study protocol, Informed consent form
Time frame: Data will become available after publication of the primary manuscript.
Access criteria: Requests for data will be submitted in writing and reviewed by the Principal Investigator.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Jason Sperry