Hemorrhage Clinical Trial
— PATCHOfficial title:
Pre-hospital Advanced Therapies for Control of Hemorrhage (PATCH) - Pelvis
NCT number | NCT02855060 |
Other study ID # | 01-15-08B |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2016 |
Est. completion date | December 2018 |
Verified date | July 2021 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Carolinas Medical Center | Charlotte | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality Rate | Percentage of patients that experience mortality within 30 days of presentation will be compared between the two study arms | 30 day | |
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. | 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. | 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 | 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 | 48 hours |
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