Pre-hospital Advanced Therapies for Control of Hemorrhage - Pelvis

Hemorrhage Clinical Trial

— PATCH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02855060
• Other study ID #: 01-15-08B
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: December 2018

Study information

• Verified date: July 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Hip Fractures
• Pelvic Fracture

Intervention

Device:
• Pelvic Binder

Locations

Country	Name	City	State
United States	Carolinas Medical Center	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality Rate	Percentage of patients that experience mortality within 30 days of presentation will be compared between the two study arms	30 day
Secondary	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.	At time of arrival to Emergency Department
Secondary	Number of Participants With Skin Complications After Pelvic Binder Application	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
Secondary	Length of Stay in Hospital	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
Secondary	Number of Patients With Blood Transfusions	Number of Blood Transfusions within the first 48 hours after hospital admission	48 hours