Hemorrhage, Pelvic Fracture
Conditions
Brief 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.
Detailed 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.
Interventions
DEVICEPelvic Binder
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality Rate | 30 day | Percentage of patients that experience mortality within 30 days of presentation will be compared between the two study arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores - Visual Analog Scale | 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. |
| Number of Participants With Skin Complications After Pelvic Binder Application | 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. |
| Length of Stay in Hospital | 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 |
| Number of Patients With Blood Transfusions | 48 hours | Number of Blood Transfusions within the first 48 hours after hospital admission |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pelvic Binder Commercially available device used to stabilize the pelvis
Pelvic Binder | 20 |
| No Binder Standard of care | 23 |
| Total | 43 |
Baseline characteristics
| Characteristic | Pelvic Binder | No Binder | Total |
|---|---|---|---|
| Age, Continuous | 33.5 years | 36.0 years | 36.0 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 20 participants | 23 participants | 43 participants |
| Sex: Female, Male Female | 5 Participants | 8 Participants | 13 Participants |
| Sex: Female, Male Male | 15 Participants | 15 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 2 / 28 |
| other Total, other adverse events | 0 / 22 | 0 / 28 |
| serious Total, serious adverse events | 0 / 22 | 0 / 28 |
Outcome results
Primary
Mortality Rate
Percentage of patients that experience mortality within 30 days of presentation will be compared between the two study arms
Time frame: 30 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pelvic Binder | Mortality Rate | 0 Participants |
| No Binder | Mortality Rate | 1 Participants |
Secondary
Length of Stay in Hospital
The total number of days the patient spent in the 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pelvic Binder | Length of Stay in Hospital | 3.0 days |
| No Binder | Length of Stay in Hospital | 7.5 days |
Secondary
Number of Participants With Skin Complications After Pelvic Binder Application
The rate of occurrence of skin complications after binder application will be documented.
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pelvic Binder | Number of Participants With Skin Complications After Pelvic Binder Application | 0 Participants |
Secondary
Number of Patients With Blood Transfusions
Number of Blood Transfusions within the first 48 hours after hospital admission
Time frame: 48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pelvic Binder | Number of Patients With Blood Transfusions | 1 Participants |
| No Binder | Number of Patients With Blood Transfusions | 5 Participants |
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.
Time frame: At time of arrival to Emergency Department
Population: Pain scores were not documented in the Emergency Department for all patients. Only patients with scores documented were included in this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pelvic Binder | Pain Scores - Visual Analog Scale | 8.5 score on a scale |
| No Binder | Pain Scores - Visual Analog Scale | 10.0 score on a scale |