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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pelvic Binder | Experimental | Commercially available device used to stabilize the pelvis |
|
| No Binder | No Intervention | Standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic Binder | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality Rate | Percentage of patients that experience mortality within 30 days of presentation will be compared between the two study arms | 30 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At time of arrival to Emergency Department |
| Number of Participants With Skin Complications After Pelvic Binder Application |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph R Hsu, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pelvic Binder | Commercially available device used to stabilize the pelvis Pelvic Binder |
| FG001 | No Binder | Standard of care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pelvic Binder | Commercially available device used to stabilize the pelvis Pelvic Binder |
| BG001 | No Binder | Standard of care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mortality Rate | Percentage of patients that experience mortality within 30 days of presentation will be compared between the two study arms | Posted | Count of Participants | Participants | 30 day |
|
|
30 day
Medical record was reviewed for all patients after 30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pelvic Binder | Commercially available device used to stabilize the pelvis Pelvic Binder |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Seymour | Atrium Health | 74-355-6969 | rachel.seymour@atriumhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2016 | Jan 7, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
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The rate of occurrence of skin complications after binder application will be documented. |
| 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 | 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 | 48 hours |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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. | Pain scores were not documented in the Emergency Department for all patients. Only patients with scores documented were included in this analysis. | Posted | Median | Inter-Quartile Range | score on a scale | At time of arrival to Emergency Department |
|
|
|
| Secondary | Number of Participants With Skin Complications After Pelvic Binder Application | The rate of occurrence of skin complications after binder application will be documented. | Posted | Count of Participants | Participants | From date of randomization to date of discharge or date of death from any cause, whichever came first, assessed up to 1 year |
|
|
|
| Secondary | Length of Stay in Hospital | The total number of days the patient spent in the hospital | Posted | Median | Inter-Quartile Range | days | From date of admission to date of discharge or date of death from any cause, whichever came first, assessed up to 1 year |
|
|
|
| Secondary | Number of Patients With Blood Transfusions | Number of Blood Transfusions within the first 48 hours after hospital admission | Posted | Count of Participants | Participants | 48 hours |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | No Binder | Standard of care | 2 | 28 | 0 | 28 | 0 | 28 |
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| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |