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

April 19, 2022 updated by: Wake Forest University Health Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 62 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pelvic Binder
Commercially available device used to stabilize the pelvis
Device: Pelvic Binder
No Intervention: No Binder
Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Scores - Visual Analog Scale
Time Frame: At time of arrival to Emergency Department
Pain scores at presentation to hospital will be compared between the two study arms. Range 0-10. Higher scores indicate a worse outcome.
At time of arrival to Emergency Department
Number of Participants With Skin Complications After Pelvic Binder Application
Time Frame: 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.
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
Time Frame: 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
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
Time Frame: 48 hours
Number of Blood Transfusions within the first 48 hours after hospital admission
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

July 27, 2016

First Submitted That Met QC Criteria

August 1, 2016

First Posted (Estimate)

August 4, 2016

Study Record Updates

Last Update Posted (Actual)

April 21, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-15-08B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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