Trial Outcomes & Findings for Pre-hospital Advanced Therapies for Control of Hemorrhage

Results Overview

Percentage of patients that experience mortality within 30 days of presentation will be compared between the two study arms

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

30 day

Results posted on

2022-04-21

Participant Flow

Participant milestones

Participant milestones
Measure	Pelvic Binder Commercially available device used to stabilize the pelvis Pelvic Binder	No Binder Standard of care
Overall Study STARTED	22	28
Overall Study COMPLETED	20	23
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pelvic Binder n=20 Participants Commercially available device used to stabilize the pelvis Pelvic Binder	No Binder n=23 Participants Standard of care	Total n=43 Participants Total of all reporting groups
Age, Continuous	33.5 years n=20 Participants	36.0 years n=23 Participants	36.0 years n=43 Participants
Sex: Female, Male Female	5 Participants n=20 Participants	8 Participants n=23 Participants	13 Participants n=43 Participants
Sex: Female, Male Male	15 Participants n=20 Participants	15 Participants n=23 Participants	30 Participants n=43 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	20 participants n=20 Participants	23 participants n=23 Participants	43 participants n=43 Participants

PRIMARY outcome

Timeframe: 30 day

Percentage of patients that experience mortality within 30 days of presentation will be compared between the two study arms

Outcome measures

Outcome measures
Measure	Pelvic Binder n=20 Participants Commercially available device used to stabilize the pelvis Pelvic Binder	No Binder n=23 Participants Standard of care
Mortality Rate	0 Participants	1 Participants

SECONDARY outcome

Timeframe: At time of arrival to Emergency Department

Population: Pain scores were not documented in the Emergency Department for all patients. Only patients with scores documented were included in this analysis.

Pain scores at presentation to hospital will be compared between the two study arms. Range 0-10. Higher scores indicate a worse outcome.

Outcome measures

Outcome measures
Measure	Pelvic Binder n=12 Participants Commercially available device used to stabilize the pelvis Pelvic Binder	No Binder n=15 Participants Standard of care
Pain Scores - Visual Analog Scale	8.5 score on a scale Interval 7.5 to 10.0	10.0 score on a scale Interval 7.0 to 10.0

SECONDARY outcome

Timeframe: From date of randomization to date of discharge or date of death from any cause, whichever came first, assessed up to 1 year

The rate of occurrence of skin complications after binder application will be documented.

Outcome measures

Outcome measures
Measure	Pelvic Binder n=20 Participants Commercially available device used to stabilize the pelvis Pelvic Binder	No Binder Standard of care
Number of Participants With Skin Complications After Pelvic Binder Application	0 Participants	—

SECONDARY outcome

Timeframe: From date of admission to date of discharge or date of death from any cause, whichever came first, assessed up to 1 year

The total number of days the patient spent in the hospital

Outcome measures

Outcome measures
Measure	Pelvic Binder n=20 Participants Commercially available device used to stabilize the pelvis Pelvic Binder	No Binder n=23 Participants Standard of care
Length of Stay in Hospital	3.0 days Interval 0.0 to 10.0	7.5 days Interval 2.5 to 16.5

SECONDARY outcome

Timeframe: 48 hours

Number of Blood Transfusions within the first 48 hours after hospital admission

Outcome measures

Outcome measures
Measure	Pelvic Binder n=20 Participants Commercially available device used to stabilize the pelvis Pelvic Binder	No Binder n=23 Participants Standard of care
Number of Patients With Blood Transfusions	1 Participants	5 Participants

Adverse Events

Pelvic Binder

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Binder

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rachel Seymour

Atrium Health

Phone: 74-355-6969

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place