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

Primary Purpose

Hemorrhage, Pelvic Fracture

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pelvic Binder
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhage

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Carolinas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pelvic Binder

No Binder

Arm Description

Commercially available device used to stabilize the pelvis

Standard of care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain Scores - Visual Analog Scale
Pain scores at presentation to hospital will be compared between the two study arms. Range 0-10. Higher scores indicate a worse outcome.
Number of Participants With Skin Complications After Pelvic Binder Application
The rate of occurrence of skin complications after binder application will be documented.
Length of Stay in Hospital
The total number of days the patient spent in the hospital
Number of Patients With Blood Transfusions
Number of Blood Transfusions within the first 48 hours after hospital admission

Full Information

First Posted
July 27, 2016
Last Updated
April 19, 2022
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02855060
Brief Title
Pre-hospital Advanced Therapies for Control of Hemorrhage - Pelvis
Acronym
PATCH
Official Title
Pre-hospital Advanced Therapies for Control of Hemorrhage (PATCH) - Pelvis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage, Pelvic Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pelvic Binder
Arm Type
Experimental
Arm Description
Commercially available device used to stabilize the pelvis
Arm Title
No Binder
Arm Type
No Intervention
Arm Description
Standard of care
Intervention Type
Device
Intervention Name(s)
Pelvic Binder
Primary Outcome Measure Information:
Title
Mortality Rate
Description
Percentage of patients that experience mortality within 30 days of presentation will be compared between the two study arms
Time Frame
30 day
Secondary Outcome Measure Information:
Title
Pain Scores - Visual Analog Scale
Description
Pain scores at presentation to hospital will be compared between the two study arms. Range 0-10. Higher scores indicate a worse outcome.
Time Frame
At time of arrival to Emergency Department
Title
Number of Participants With Skin Complications After Pelvic Binder Application
Description
The rate of occurrence of skin complications after binder application will be documented.
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
Title
Length of Stay in Hospital
Description
The total number of days the patient spent in the 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
Title
Number of Patients With Blood Transfusions
Description
Number of Blood Transfusions within the first 48 hours after hospital admission
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph R Hsu, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Pre-hospital Advanced Therapies for Control of Hemorrhage - Pelvis

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