Pelvic FractureEMS-BINDNCT03977168
A Prospective Study of Early Mechanical Stabilization and Bleeding in Disruption of the Pelvic Ring
An observational study of Pelvic Fracture, run by Major Extremity Trauma Research Consortium at 11 sites in United States.
Trial summary
The objective of this study is to evaluate the effect of earlier placement of Circumferential Pelvic Compression (CPC) on resuscitative measures required for life-threatening pelvic ring injuries and to guide the development of future efficacy trials of three advanced resuscitation techniques (surgical pelvic packing… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Pelvic Fracture
- What is being tested?
- Application of circumferential pelvic compression (CPC) device
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 11 sitesUnited States
- Study dates
- 17 May 2019to Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients with severe pelvic ring disruptions
Who may be able to join
- Patient age between 18 and 64 years, inclusive;
- Severe blunt or blast traumatic injury;
- Young-Burgess APC-2 and 3, LC-3, vertical shear, and combined mechanism of injury (CMI) (Tile B and C patterns; OTA codes 61-B and 61-C);
- Circumferential pelvic compression (CPC) device used at any time within 24 hours of injury.
- Patient must speak either English or Spanish
Who cannot join
- Arrival to hospital of definitive care more than 6 hours after injury;
- Ballistic pelvic injury, other than from a blast mechanism;
- Time of CPC placement not recorded;
- Time of injury and time of EMS dispatch unknown;
- Use of medical anti-shock trousers (MAST);
- Confirmed dead on arrival to hospital
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Maryland R Adams Cowley Shock Trauma Center
Baltimore, Maryland, 21201
Boston Medical Center
Boston, Massachusetts, 02118
Carolinas Medical Center
Charlotte, North Carolina, 28203
University of Texas Health Science Center - Houston
Houston, Texas, 77030
Methodist Hospital
Indianapolis, Indiana, 46202
University of Miami Ryder Trauma Center
Miami, Florida, 33136
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
San Antonio Military Medical Center (SAMMC)
San Antonio, Texas, 78234
University of Washington/Harborview Medical Center
Seattle, Washington, 98104
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
The objective of this study is to evaluate the effect of earlier placement of Circumferential Pelvic Compression (CPC) on resuscitative measures required for life-threatening pelvic ring injuries and to guide the development of future efficacy trials of three advanced resuscitation techniques (surgical pelvic packing, angioembolization, REBOA).
- Conditions
- Pelvic Fracture
- Being tested
- Application of circumferential pelvic compression (CPC) device
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of circumferential pelvic compression (CPC) deviceProcedure or surgery
Application of circumferential pelvic compression (CPC) device used at any time within 24 hours of injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood products
We will document the volume of any blood products given within the first 24 hours following injury
Measured: 24 hours
Pelvic stabilization and resuscitative techniques
We will document any techniques used to stabilize and/or resuscitate the pelvic injury within the first 24 hours
Measured: 24 hours
Secondary outcomes (5)
Blood loss
Total blood volume loss will be calculated within the first 24 hours following injury
Measured: 24 hours
Ventilator days
Number of days that patient spends on a ventilator will be documented
Measured: 24 hours
ICU days
Number of days spent in the ICU will be documented
Measured: 24 hours
Length of hospital stay
Number of days spent in the hospital will be documented
Measured: 24 hours
GCS (Glascow Coma Score)
The GCS is a neurological scale to assess for brain injury. The score is composed of three parts: eyes, verbal and motor. Each component has a different scale. Eyes (1-4), verbal (1-5) and motor (1-6). The sum of all three components result in the overall GCS score (3-15). The higher the score, the less likelihood of brain injury
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start17 May 2019
- Primary completion30 Jun 2022
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic FractureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Major Extremity Trauma Research Consortium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977168
- Sponsor's protocol ID
- W81XWH-16-2-0060-EMS-BIND
- Acronym
- EMS-BIND
- Status last verified
- Aug 2022
- First submitted
- 4 Jun 2019
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Early Mechanical Stabilization and Bleeding in Disruption of the Pelvic Ring
- ClinicalTrials.gov ID
- NCT03977168
- Acronym / sponsor ID
- EMS-BIND / W81XWH-16-2-0060-EMS-BIND
- Conditions
- Pelvic Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Major Extremity Trauma Research ConsortiumUniversity, hospital or other
- Study start
- 17 May 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- Sep 2022 (estimated)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the effect of earlier placement of Circumferential Pelvic Compression (CPC) on resuscitative measures required for life-threatening pelvic ring injuries and to guide the development of future efficacy trials of three advanced resuscitation techniques (surgical pelvic packing, angioembolization, REBOA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with severe pelvic ring disruptions
Key inclusion criteria (5 listed)
- Patient age between 18 and 64 years, inclusive;
- Severe blunt or blast traumatic injury;
- Young-Burgess APC-2 and 3, LC-3, vertical shear, and combined mechanism of injury (CMI) (Tile B and C patterns; OTA codes 61-B and 61-C);
- Circumferential pelvic compression (CPC) device used at any time within 24 hours of injury.
- Patient must speak either English or Spanish
Key exclusion criteria (6 listed)
- Arrival to hospital of definitive care more than 6 hours after injury;
- Ballistic pelvic injury, other than from a blast mechanism;
- Time of CPC placement not recorded;
- Time of injury and time of EMS dispatch unknown;
- Use of medical anti-shock trousers (MAST);
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 |
|---|---|---|
| Application of circumferential pelvic compression (CPC) deviceApplication of circumferential pelvic compression (CPC) device used at any time within 24 hours of injury | Procedure or surgery | – |
Primary outcome
Blood products
Time frame: 24 hours
We will document the volume of any blood products given within the first 24 hours following injury
Pelvic stabilization and resuscitative techniques
Time frame: 24 hours
We will document any techniques used to stabilize and/or resuscitate the pelvic injury within the first 24 hours
5 secondary outcomes
Blood loss
Time frame: 24 hours
Ventilator days
Time frame: 24 hours
ICU days
Time frame: 24 hours
Length of hospital stay
Time frame: 24 hours
GCS (Glascow Coma Score)
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Fracture, run by Major Extremity Trauma Research Consortium at 11 sites 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
Results are not available in the source record.
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?
Blood products (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 30 Aug 2022.