Pre-hospital Advanced Therapies for Control of Hemorrhage - Pelvis
PATCH
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of this study is to determine whether the use of pelvic binders in the ambulance setting improves outcomes including mortality in patients with pelvic fractures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 27, 2016
CompletedFirst Posted
Study publicly available on registry
August 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedResults Posted
Study results publicly available
August 2, 2021
CompletedApril 21, 2022
July 1, 2021
1.9 years
July 27, 2016
January 7, 2020
April 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Mortality Rate
Percentage of patients that experience mortality within 30 days of presentation will be compared between the two study arms
30 day
Secondary Outcomes (4)
Pain Scores - Visual Analog Scale
At time of arrival to Emergency Department
Number of Participants With Skin Complications After Pelvic Binder Application
From date of randomization to date of discharge or date of death from any cause, whichever came first, assessed up to 1 year
Length of Stay in Hospital
From date of admission to date of discharge or date of death from any cause, whichever came first, assessed up to 1 year
Number of Patients With Blood Transfusions
48 hours
Study Arms (2)
Pelvic Binder
EXPERIMENTALCommercially available device used to stabilize the pelvis
No Binder
NO INTERVENTIONStandard of care
Interventions
Eligibility Criteria
You may qualify if:
- Traumatic injury other than ground-level fall, and
- Complaint of pelvic groin or hip pain, or
- Pelvic or hip deformity, ecchymosis, or crepitus in an obtunded patient, or
- Hemodynamic instability
You may not qualify if:
- Ground level fall
- Penetrating pelvis injury without frank evidence of fracture
- Obviously pregnant patients
- Patients who are too small or too big for the binder
- Priority 2 or 3 Trauma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Rachel Seymour
- Organization
- Atrium Health
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph R Hsu, MD
Wake Forest University Health Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2016
First Posted
August 4, 2016
Study Start
July 1, 2016
Primary Completion
June 1, 2018
Study Completion
December 1, 2018
Last Updated
April 21, 2022
Results First Posted
August 2, 2021
Record last verified: 2021-07