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Clinical Trials/NCT02855060
NCT02855060
Completed
Not Applicable

Pre-hospital Advanced Therapies for Control of Hemorrhage (PATCH) - Pelvis

Wake Forest University Health Sciences1 site in 1 country50 target enrollmentJuly 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemorrhage
Sponsor
Wake Forest University Health Sciences
Enrollment
50
Locations
1
Primary Endpoint
Mortality Rate
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2016
End Date
December 2018
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Mortality Rate

Time Frame: 30 day

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

Secondary Outcomes

  • 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 Sites (1)

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