Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-03-09 @ 2:35 AM
Study NCT ID:
NCT02855060
Status:
COMPLETED
Last Update Posted:
2022-04-21
First Post:
2016-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pre-hospital Advanced Therapies for Control of Hemorrhage - Pelvis
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
Pre-hospital Advanced Therapies for Control of Hemorrhage (PATCH) - Pelvis
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PATCH
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.
Detailed Description:
The goal of this prospective, randomized clinical trial is to determine whether prehospital use of a commercial pelvic binder will improve morbidity and mortality in patients with pelvic fractures. We hypothesize that prehospital placement of pelvic binders will reduce hemorrhage and need for resuscitation and will improve overall mortality in patients with pelvic fractures. In addition, we hypothesize that pelvic splinting via external compression will improve patients' pain regardless of whether they have a pelvic, acetabular, or proximal femur fracture.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: