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

Wake Forest University (WFU) logo

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)

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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