Trial · NCT04726410

Cold-stored Platelet Early Intervention in TBI

NCT04726410, Phase 2, Completed, Jason Sperry; results first posted 2025-04-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Cold-stored Platelet Early Intervention in TBI. Trials, record NCT04726410. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04726410

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Cold-stored Platelet Early Intervention in TBI
NCT number: NCT04726410
Status: Completed
Phases: Phase 2
Enrollment: 100 participants, actual
Lead sponsor: Jason Sperry
Conditions: Traumatic Brain Injury
Interventions: Cold Stored Platelets, Standard Care
First posted: 2021-01-27
Last updated: 2025-05-11
Results first posted: 2025-04-29

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Study Feasibility	6 months	proportion of eligible patients that can be randomized, enrolled, adhere to protocol, and complete follow-up
Secondary	6-month Extended Glasgow Outcome Scale (GOS-E)	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).
Secondary	24-hour Mortality	Enrollment through 24 hours	Mortality within 24 hours
Secondary	In-hospital Mortality	Enrollment through discharge up to 6 months	Mortality in-hospital
Secondary	TBI Progression	Enrollment through 24 hours	Evidence of progression of TBI. Common Data Elements for CT scan indicators of TBI progression will be utilized.
Secondary	Galveston Orientation and Amnesia Test (GOAT)	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
Secondary	Incidence of Allergic/Transfusion Reaction	Enrollment through 24 hours	Any transfusion complication in Emergency Department or Operating Room
Secondary	Incidence of Transfusion Related Acute Lung Injury (TRALI)	Enrollment through 48 hours	Occurrence of Acute Respiratory Distress Syndrome (ARDS) within 6 hours of transfusion of platelets
Secondary	Incidence of Thromboembolic Events	Enrollment through 48 hours	Incidence of pulmonary embolism, venous thrombosis, or arterial thrombosis

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Study Feasibility	6 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	6-month Extended Glasgow Outcome Scale (GOS-E)	6 months after enrollment	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	24-hour Mortality	Enrollment through 24 hours	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	In-hospital Mortality	Enrollment through discharge up to 6 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	TBI Progression	Enrollment through 24 hours	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Galveston Orientation and Amnesia Test (GOAT)	At Discharge from Current Hospital Admission	score on a scale	MEDIAN
SECONDARY	Incidence of Allergic/Transfusion Reaction	Enrollment through 24 hours	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Incidence of Transfusion Related Acute Lung Injury (TRALI)	Enrollment through 48 hours	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Incidence of Thromboembolic Events	Enrollment through 48 hours	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Study Feasibility	Cold-stored Platelet (CSP)		50	Participants
Study Feasibility	Standard Care		50	Participants
6-month Extended Glasgow Outcome Scale (GOS-E)	Cold-stored Platelet (CSP)	Unfavorable	21	Participants
6-month Extended Glasgow Outcome Scale (GOS-E)	Standard Care	Unfavorable	20	Participants
6-month Extended Glasgow Outcome Scale (GOS-E)	Cold-stored Platelet (CSP)	Favorable	22	Participants
6-month Extended Glasgow Outcome Scale (GOS-E)	Standard Care	Favorable	20	Participants
24-hour Mortality	Cold-stored Platelet (CSP)		1	Participants
24-hour Mortality	Standard Care		0	Participants
In-hospital Mortality	Cold-stored Platelet (CSP)		6	Participants
In-hospital Mortality	Standard Care		7	Participants

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Cold-stored Platelet (CSP)	50
Overall Study	STARTED	Standard Care	50
Overall Study	COMPLETED	Cold-stored Platelet (CSP)	50
Overall Study	COMPLETED	Standard Care	49
Overall Study	NOT COMPLETED	Cold-stored Platelet (CSP)	0
Overall Study	NOT COMPLETED	Standard Care	1

Source ClinicalTrials.gov

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
serious	Pneumonia	Respiratory, thoracic and mediastinal disorders	Cold-stored Platelet (CSP)	3	50	3
serious	Pneumonia	Respiratory, thoracic and mediastinal disorders	Standard Care	2	49	2
serious	pulmonary consolidation	Respiratory, thoracic and mediastinal disorders	Cold-stored Platelet (CSP)	1	50	1
serious	pulmonary consolidation	Respiratory, thoracic and mediastinal disorders	Standard Care	0	49	0
serious	seizures	Nervous system disorders	Cold-stored Platelet (CSP)	0	50	0
serious	seizures	Nervous system disorders	Standard Care	1	49	1
serious	deep vein thrombosis	Vascular disorders	Cold-stored Platelet (CSP)	1	50	1
serious	deep vein thrombosis	Vascular disorders	Standard Care	0	49	0
serious	Acute kidney injury	Renal and urinary disorders	Cold-stored Platelet (CSP)	2	50	2
serious	Acute kidney injury	Renal and urinary disorders	Standard Care	1	49	1

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cold-stored Platelet (CSP)	6	50
Total, all-cause mortality	Standard Care	7	49
Total, other adverse events	Cold-stored Platelet (CSP)	0	50
Total, other adverse events	Standard Care	0	49
Total, serious adverse events	Cold-stored Platelet (CSP)	9	50
Total, serious adverse events	Standard Care	8	49

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40271704	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons9

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Cold-stored Platelet (CSP) vs Standard Care: In-hospital Mortality	Trial comparisons
Cold-stored Platelet (CSP) vs Standard Care: Study Feasibility	Trial comparisons
Cold-stored Platelet (CSP) vs Standard Care: Incidence of Transfusion Related Acute Lung Injury (TRALI)	Trial comparisons
Cold-stored Platelet (CSP) vs Standard Care: Incidence of Thromboembolic Events	Trial comparisons
Cold-stored Platelet (CSP) vs Standard Care: Incidence of Allergic/Transfusion Reaction	Trial comparisons
Cold-stored Platelet (CSP) vs Standard Care: 24-hour Mortality	Trial comparisons
Cold-stored Platelet (CSP) vs Standard Care: deaths from any cause	Trial comparisons
Cold-stored Platelet (CSP) vs Standard Care: TBI Progression	Trial comparisons
Cold-stored Platelet (CSP) vs Standard Care: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04726410

GET https://conductscience.org/api/trials/v1/NCT04726410/registered

API reference For AI assistants