HemorrhagePATCHNCT02855060
Pre-hospital Advanced Therapies for Control of Hemorrhage - Pelvis
A study testing Pelvic Binder in people with Hemorrhage and Pelvic Fracture, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Hemorrhage, Pelvic Fracture
- What is being tested?
- Pelvic Binder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas Medical Center
Charlotte, North Carolina, 28203
About this study
Official title: Pre-hospital Advanced Therapies for Control of Hemorrhage (PATCH) - Pelvis
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.
Read the 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.
- Conditions
- Hemorrhage, Pelvic Fracture
- Being tested
- Pelvic Binder
- Medical subject headings
- Hemorrhage, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic BinderDevice
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Binder | Experimental | Commercially available device used to stabilize the pelvis Receives: Device: Pelvic Binder |
| No Binder | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality Rate
Percentage of patients that experience mortality within 30 days of presentation will be compared between the two study arms
Measured: 30 day
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph R Hsu, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855060
- Sponsor's protocol ID
- 01-15-08B
- Acronym
- PATCH
- Status last verified
- Jul 2021
- First submitted
- 27 Jul 2016
- Last updated
- 21 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-hospital Advanced Therapies for Control of Hemorrhage (PATCH) - Pelvis
- ClinicalTrials.gov ID
- NCT02855060
- Acronym / sponsor ID
- PATCH / 01-15-08B
- Conditions
- Hemorrhage, Pelvic Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jun 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Posted 2 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic Binder | Experimental | Device: Pelvic BinderCommercially available device used to stabilize the pelvis |
| No Binder | No intervention | –Standard of care |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic Binder | Device | Pelvic Binder |
Primary outcome
Mortality Rate
Time frame: 30 day
Percentage of patients that experience mortality within 30 days of presentation will be compared between the two study arms
4 secondary outcomes
Pain Scores - Visual Analog Scale
Time frame: At time of arrival to Emergency Department
Number of Participants With Skin Complications After Pelvic Binder Application
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
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
Time frame: 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph R Hsu, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic Binder in people with Hemorrhage and Pelvic Fracture, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality Rate (time frame: 30 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022; AzTrials last refreshed its copy on 8 Nov 2026.