Trial Outcomes & Findings for Cold Stored Platelet in Hemorrhagic Shock (NCT NCT04667468)

NCT ID: NCT04667468

Last Updated: 2024-12-18

Results Overview

Proportion of eligible patients that can be randomized, enrolled, adhere to protocol, and completed follow-up

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 200 participants
• Primary outcome timeframe: Enrollment through 30 days or discharge
• Results posted on: 2024-12-18

Participant Flow

Participant milestones

Measure	Cold-stored Platelet (CSP) early infusion of one apheresis unit urgent release cold stored platelets (CSP) Cold Stored Platelets (CSP): early infusion of urgent release CSP	Standard Care resuscitation, blood and blood component transfusion per site standard care Standard Care: standard care including blood and blood component therapy
Overall Study STARTED	102	98
Overall Study COMPLETED	102	98
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Patients can be in more than one group.

Baseline characteristics by cohort

Measure	Cold-stored Platelet (CSP) n=102 Participants early infusion of one apheresis unit urgent release cold stored platelets (CSP) Cold Stored Platelets (CSP): early infusion of urgent release CSP	Standard Care n=98 Participants resuscitation, blood and blood component transfusion per site standard care Standard Care: standard care including blood and blood component therapy	Total n=200 Participants Total of all reporting groups
Age, Continuous	35.3 years STANDARD_DEVIATION 14.4 • n=5 Participants	34.4 years STANDARD_DEVIATION 13.5 • n=7 Participants	34.8 years STANDARD_DEVIATION 13.9 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	20 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	85 Participants n=5 Participants	78 Participants n=7 Participants	163 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	28 Participants n=5 Participants • Patients can be in more than one group.	18 Participants n=7 Participants • Patients can be in more than one group.	46 Participants n=5 Participants • Patients can be in more than one group.
Race/Ethnicity, Customized Black	47 Participants n=5 Participants • Patients can be in more than one group.	51 Participants n=7 Participants • Patients can be in more than one group.	98 Participants n=5 Participants • Patients can be in more than one group.
Race/Ethnicity, Customized Hispanic	20 Participants n=5 Participants • Patients can be in more than one group.	13 Participants n=7 Participants • Patients can be in more than one group.	33 Participants n=5 Participants • Patients can be in more than one group.
Race/Ethnicity, Customized Other including Asian and unknown	13 Participants n=5 Participants • Patients can be in more than one group.	13 Participants n=7 Participants • Patients can be in more than one group.	26 Participants n=5 Participants • Patients can be in more than one group.
Race/Ethnicity, Customized Missing	0 Participants n=5 Participants • Patients can be in more than one group.	3 Participants n=7 Participants • Patients can be in more than one group.	3 Participants n=5 Participants • Patients can be in more than one group.

PRIMARY outcome

Timeframe: Enrollment through 30 days or discharge

Proportion of eligible patients that can be randomized, enrolled, adhere to protocol, and completed follow-up

Outcome measures

Measure	Cold-stored Platelet (CSP) n=102 Participants early infusion of one apheresis unit urgent release cold stored platelets (CSP) Cold Stored Platelets (CSP): early infusion of urgent release CSP	Standard Care n=98 Participants resuscitation, blood and blood component transfusion per site standard care Standard Care: standard care including blood and blood component therapy
Study Feasibility	91 Participants	82 Participants

SECONDARY outcome

Timeframe: Enrollment through 24 hours

Mortality within 24 hours

Outcome measures

Measure	Cold-stored Platelet (CSP) n=102 Participants early infusion of one apheresis unit urgent release cold stored platelets (CSP) Cold Stored Platelets (CSP): early infusion of urgent release CSP	Standard Care n=98 Participants resuscitation, blood and blood component transfusion per site standard care Standard Care: standard care including blood and blood component therapy
24-hour Mortality	6 Participants	10 Participants

SECONDARY outcome

Timeframe: Enrollment through 3 hours

Mortality within 3 hours

Outcome measures

Measure	Cold-stored Platelet (CSP) n=102 Participants early infusion of one apheresis unit urgent release cold stored platelets (CSP) Cold Stored Platelets (CSP): early infusion of urgent release CSP	Standard Care n=98 Participants resuscitation, blood and blood component transfusion per site standard care Standard Care: standard care including blood and blood component therapy
3-hour Mortality	6 Participants	7 Participants

SECONDARY outcome

Timeframe: Enrollment through 30 days or discharge

mortality in-hospital

Outcome measures

Measure	Cold-stored Platelet (CSP) n=91 Participants early infusion of one apheresis unit urgent release cold stored platelets (CSP) Cold Stored Platelets (CSP): early infusion of urgent release CSP	Standard Care n=82 Participants resuscitation, blood and blood component transfusion per site standard care Standard Care: standard care including blood and blood component therapy
In Hospital Mortality	12 Participants	13 Participants

SECONDARY outcome

Timeframe: Enrollment through 24 hours

mortality due to hemorrhage

Outcome measures

Measure	Cold-stored Platelet (CSP) n=102 Participants early infusion of one apheresis unit urgent release cold stored platelets (CSP) Cold Stored Platelets (CSP): early infusion of urgent release CSP	Standard Care n=98 Participants resuscitation, blood and blood component transfusion per site standard care Standard Care: standard care including blood and blood component therapy
Hemorrhagic Death Alone	6 Participants	7 Participants

SECONDARY outcome

Timeframe: Enrollment through 48 hours

Berlin definition of mild ARDS will determine incidence and will be further stratified into Moderate and Severe

Outcome measures

Measure	Cold-stored Platelet (CSP) n=100 Participants early infusion of one apheresis unit urgent release cold stored platelets (CSP) Cold Stored Platelets (CSP): early infusion of urgent release CSP	Standard Care n=93 Participants resuscitation, blood and blood component transfusion per site standard care Standard Care: standard care including blood and blood component therapy
Incidence of Acute Respiratory Distress Syndrome (ARDS)	6 Participants	3 Participants

SECONDARY outcome

Timeframe: Enrollment through 48 hours

Incidence of pulmonary embolism, venous thrombosis, or arterial thrombosis

Outcome measures

Measure	Cold-stored Platelet (CSP) n=100 Participants early infusion of one apheresis unit urgent release cold stored platelets (CSP) Cold Stored Platelets (CSP): early infusion of urgent release CSP	Standard Care n=93 Participants resuscitation, blood and blood component transfusion per site standard care Standard Care: standard care including blood and blood component therapy
Incidence of Thromboembolic Events	10 Participants	10 Participants

SECONDARY outcome

Timeframe: Enrollment through 30 days

mortality within 30 days

Outcome measures

Measure	Cold-stored Platelet (CSP) n=91 Participants early infusion of one apheresis unit urgent release cold stored platelets (CSP) Cold Stored Platelets (CSP): early infusion of urgent release CSP	Standard Care n=82 Participants resuscitation, blood and blood component transfusion per site standard care Standard Care: standard care including blood and blood component therapy
30-day Mortality	12 Participants	13 Participants

Adverse Events

Cold-stored Platelet (CSP)

Serious events: 9 serious events

Other events: 0 other events

Deaths: 12 deaths

Standard Care

Serious events: 4 serious events

Other events: 0 other events

Deaths: 13 deaths

Serious adverse events

Measure	Cold-stored Platelet (CSP) n=102 participants at risk early infusion of one apheresis unit urgent release cold stored platelets (CSP) Cold Stored Platelets (CSP): early infusion of urgent release CSP	Standard Care n=98 participants at risk resuscitation, blood and blood component transfusion per site standard care Standard Care: standard care including blood and blood component therapy
Vascular disorders Thromboembolic events	5.9% 6/102 • Number of events 6 • 30 days	3.1% 3/98 • Number of events 3 • 30 days
Blood and lymphatic system disorders Coagulopathy	0.98% 1/102 • Number of events 1 • 30 days	0.00% 0/98 • 30 days
Respiratory, thoracic and mediastinal disorders Pneumonia	0.98% 1/102 • Number of events 1 • 30 days	1.0% 1/98 • Number of events 1 • 30 days
Cardiac disorders Transfusion Associated Cardiac Overload	0.98% 1/102 • Number of events 1 • 30 days	0.00% 0/98 • 30 days

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jason Sperry

University of Pittsburgh

Phone: 412-215-7025

Email: sperryjl@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place