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Completed

NCT Number: NCT02855060

Pre-hospital Advanced Therapies for Control of Hemorrhage - 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.

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Key information

Conditions

Hemorrhage Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Fracture Wounds and Injuries

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pelvic binder

Device

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. Number of Patients With Blood Transfusions

    Time frame: 48 hours

    Number of Blood Transfusions within the first 48 hours after hospital admission

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Acronym: PATCH

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 4, 2016
Registry last updated
Apr 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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