An interventional study of Pelvic Binder in Hemorrhage and Pelvic Fracture, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2022-04-21.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
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.
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.
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
This study's enrollment of 50 is below the median of 100 across 1,985 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Commercially available device used to stabilize the pelvis
Device: Pelvic Binder
Standard of care
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
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
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
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
Number of Patients With Blood Transfusions
Number of Blood Transfusions within the first 48 hours after hospital admission
Time frame: 48 hours
| Milestone | Pelvic Binder | No Binder |
|---|---|---|
| Started | 22 | 28 |
| Completed | 20 | 23 |
| Not completed | 2 | 5 |
Percentage of patients that experience mortality within 30 days of presentation will be compared between the two study arms
| Participants | Pelvic Binder | No Binder |
|---|---|---|
| Mortality Rate | 0 | 1 |
Pain scores at presentation to hospital will be compared between the two study arms. Range 0-10. Higher scores indicate a worse outcome.
| score on a scale | Pelvic Binder | No Binder |
|---|---|---|
| Pain Scores - Visual Analog Scale | 8.5 (7.5 to 10) | 10.0 (7.0 to 10.0) |
The rate of occurrence of skin complications after binder application will be documented.
| Participants | Pelvic Binder |
|---|---|
| Number of Participants With Skin Complications After Pelvic Binder Application | 0 |
The total number of days the patient spent in the hospital
| days | Pelvic Binder | No Binder |
|---|---|---|
| Length of Stay in Hospital | 3.0 (0 to 10) | 7.5 (2.5 to 16.5) |
Number of Blood Transfusions within the first 48 hours after hospital admission
| Participants | Pelvic Binder | No Binder |
|---|---|---|
| Number of Patients With Blood Transfusions | 1 | 5 |
Collected over 30 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pelvic Binder | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| No Binder | 2/28 (7.1%) | 0/28 (0%) | 0/28 (0%) |
| Age, Continuous(years) | Pelvic Binder | No Binder | Total |
|---|---|---|---|
| Median | 33.5 (27.0 to 45.0) | 36.0 (24.0 to 49.0) | 36.0 (26.0 to 47.0) |
| Sex: Female, Male(Participants) | Pelvic Binder | No Binder | Total |
|---|---|---|---|
| Female | 5 | 8 | 13 |
| Male | 15 | 15 | 30 |
| Race and Ethnicity Not Collected(Participants) | Pelvic Binder | No Binder | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Pelvic Binder | No Binder | Total |
|---|---|---|---|
| United States | 20 | 23 | 43 |
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Plan to share: Undecided
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences