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

Wake Forest University (WFU)

Status: Completed

Conditions: Hemorrhage; Pelvic Fracture

Treatments: Device: Pelvic Binder

Study type: Interventional

Funder types: Other

Identifiers

NCT02855060

01-15-08B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Pelvic Binder

Experimental group

Description:

Commercially available device used to stabilize the pelvis

Treatment:

Device: Pelvic Binder

No Binder

No Intervention group

Description:

Standard of care