Trial Outcomes & Findings for Cold-stored Platelet Early Intervention in TBI (NCT NCT04726410)

NCT ID: NCT04726410

Last Updated: 2025-05-11

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 100 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2025-05-11

Participant Flow

Participant milestones

Measure	Cold-stored Platelet (CSP) early infusion of up to 2 units of urgent release cold stored platelets (CSP) Cold Stored Platelets: early infusion of urgent release CSP	Standard Care standard care therapy Standard Care: standard care including room temperature platelets
Overall Study STARTED	50	50
Overall Study COMPLETED	50	49
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cold-stored Platelet Early Intervention in TBI

Baseline characteristics by cohort

Measure	Cold-stored Platelet (CSP) n=50 Participants early infusion of up to 2 units of urgent release cold stored platelets (CSP) Cold Stored Platelets: early infusion of urgent release CSP	Standard Care n=50 Participants standard care therapy Standard Care: standard care including room temperature platelets	Total n=100 Participants Total of all reporting groups
Age, Continuous	73.5 years n=5 Participants	78 years n=7 Participants	76 years n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	26 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	44 Participants n=5 Participants	37 Participants n=7 Participants	81 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

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

Outcome measures

Measure	Cold-stored Platelet (CSP) n=50 Participants early infusion of up to 2 units of urgent release cold stored platelets (CSP) Cold Stored Platelets: early infusion of urgent release CSP	Standard Care n=50 Participants standard care therapy Standard Care: standard care including room temperature platelets
Study Feasibility	50 Participants	50 Participants

SECONDARY outcome

Timeframe: 6 months after enrollment

A tool used to characterize 6-month functional status into 8 defined categories, with 1 being the worst (death) to 8 being the most favorable (good recovery).

Outcome measures

Measure	Cold-stored Platelet (CSP) n=43 Participants early infusion of up to 2 units of urgent release cold stored platelets (CSP) Cold Stored Platelets: early infusion of urgent release CSP	Standard Care n=40 Participants standard care therapy Standard Care: standard care including room temperature platelets
6-month Extended Glasgow Outcome Scale (GOS-E) Unfavorable	21 Participants	20 Participants
6-month Extended Glasgow Outcome Scale (GOS-E) Favorable	22 Participants	20 Participants

SECONDARY outcome

Timeframe: Enrollment through 24 hours

Mortality within 24 hours

Outcome measures

Measure	Cold-stored Platelet (CSP) n=50 Participants early infusion of up to 2 units of urgent release cold stored platelets (CSP) Cold Stored Platelets: early infusion of urgent release CSP	Standard Care n=49 Participants standard care therapy Standard Care: standard care including room temperature platelets
24-hour Mortality	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Enrollment through discharge up to 6 months

Mortality in-hospital

Outcome measures

Measure	Cold-stored Platelet (CSP) n=50 Participants early infusion of up to 2 units of urgent release cold stored platelets (CSP) Cold Stored Platelets: early infusion of urgent release CSP	Standard Care n=49 Participants standard care therapy Standard Care: standard care including room temperature platelets
In-hospital Mortality	6 Participants	7 Participants

SECONDARY outcome

Timeframe: Enrollment through 24 hours

Evidence of progression of TBI. Common Data Elements for CT scan indicators of TBI progression will be utilized.

Outcome measures

Measure	Cold-stored Platelet (CSP) n=48 Participants early infusion of up to 2 units of urgent release cold stored platelets (CSP) Cold Stored Platelets: early infusion of urgent release CSP	Standard Care n=47 Participants standard care therapy Standard Care: standard care including room temperature platelets
TBI Progression	8 Participants	11 Participants

SECONDARY outcome

Timeframe: At Discharge from Current Hospital Admission

10-item questionnaire used to quickly assess post-traumatic amnesia following head injury. The GOAT is read orally to the patient and may be easily administered at the bedside. The total score accounts for orientation of person, place, and time, and recollection of events pre and post- injury. Cutoff scores are available to identify abnormal, borderline, and normal orientation. The total GOAT score is obtained by deducting the sum of the error points from each incorrect response from 100.Range is 0-100. A score of 66 or lower is categorized as "impaired," 66-75 as "borderline," and 76-100 as "normal." This will be obtained At Discharge from Current Hospital Admission

Outcome measures

Measure	Cold-stored Platelet (CSP) n=38 Participants early infusion of up to 2 units of urgent release cold stored platelets (CSP) Cold Stored Platelets: early infusion of urgent release CSP	Standard Care n=36 Participants standard care therapy Standard Care: standard care including room temperature platelets
Galveston Orientation and Amnesia Test (GOAT)	95 score on a scale Interval 72.0 to 100.0	91 score on a scale Interval 71.0 to 100.0

SECONDARY outcome

Timeframe: Enrollment through 24 hours

Any transfusion complication in Emergency Department or Operating Room

Outcome measures

Measure	Cold-stored Platelet (CSP) n=50 Participants early infusion of up to 2 units of urgent release cold stored platelets (CSP) Cold Stored Platelets: early infusion of urgent release CSP	Standard Care n=49 Participants standard care therapy Standard Care: standard care including room temperature platelets
Incidence of Allergic/Transfusion Reaction	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Enrollment through 48 hours

Occurrence of Acute Respiratory Distress Syndrome (ARDS) within 6 hours of transfusion of platelets

Outcome measures

Measure	Cold-stored Platelet (CSP) n=50 Participants early infusion of up to 2 units of urgent release cold stored platelets (CSP) Cold Stored Platelets: early infusion of urgent release CSP	Standard Care n=49 Participants standard care therapy Standard Care: standard care including room temperature platelets
Incidence of Transfusion Related Acute Lung Injury (TRALI)	0 Participants	0 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=50 Participants early infusion of up to 2 units of urgent release cold stored platelets (CSP) Cold Stored Platelets: early infusion of urgent release CSP	Standard Care n=49 Participants standard care therapy Standard Care: standard care including room temperature platelets
Incidence of Thromboembolic Events	1 Participants	0 Participants

Adverse Events

Cold-stored Platelet (CSP)

Serious events: 9 serious events

Other events: 0 other events

Deaths: 6 deaths

Standard Care

Serious events: 8 serious events

Other events: 0 other events

Deaths: 7 deaths

Serious adverse events

Measure	Cold-stored Platelet (CSP) n=50 participants at risk early infusion of up to 2 units of urgent release cold stored platelets (CSP) Cold Stored Platelets: early infusion of urgent release CSP	Standard Care n=49 participants at risk standard care therapy Standard Care: standard care including room temperature platelets
Respiratory, thoracic and mediastinal disorders Pneumonia	6.0% 3/50 • Number of events 3 • 6 months	4.1% 2/49 • Number of events 2 • 6 months
Respiratory, thoracic and mediastinal disorders pulmonary consolidation	2.0% 1/50 • Number of events 1 • 6 months	0.00% 0/49 • 6 months
Nervous system disorders seizures	0.00% 0/50 • 6 months	2.0% 1/49 • Number of events 1 • 6 months
Vascular disorders deep vein thrombosis	2.0% 1/50 • Number of events 1 • 6 months	0.00% 0/49 • 6 months
Renal and urinary disorders Acute kidney injury	4.0% 2/50 • Number of events 2 • 6 months	2.0% 1/49 • Number of events 1 • 6 months
Infections and infestations other	4.0% 2/50 • Number of events 2 • 6 months	8.2% 4/49 • Number of events 4 • 6 months

Other adverse events

Adverse event data not reported

Additional Information

Jason Sperry

University of Pittsburgh

Phone: 4128028270

Email: sperryjl@upmc.edu

Results disclosure agreements

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