N/A
N=50
Pre-hospital Advanced Therapies for Control of Hemorrhage - Pelvis
Hemorrhage · Pelvic Fracture
Bottom Line
View on ClinicalTrials.gov: NCT02855060 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Mortality Rate — 0; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pelvic Binder (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mortality Rate |
0; 1 | — |
| SECONDARY Pain Scores - Visual Analog Scale |
8.5; 10.0 | — |
| SECONDARY Number of Participants With Skin Complications After Pelvic Binder Application |
— | — |
| SECONDARY Length of Stay in Hospital |
3.0; 7.5 | — |
| SECONDARY Number of Patients With Blood Transfusions |
1; 5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02855060). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.