Pelvic Fracture Clinical Trial
— EMS-BINDOfficial title:
A Prospective Study of Early Mechanical Stabilization and Bleeding in Disruption of the Pelvic Ring
Verified date | August 2022 |
Source | Major Extremity Trauma Research Consortium |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Enrolling by invitation |
Enrollment | 600 |
Est. completion date | September 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland R Adams Cowley Shock Trauma Center | Baltimore | Maryland |
United States | Boston Medical Center | Boston | Massachusetts |
United States | Carolinas Medical Center | Charlotte | North Carolina |
United States | University of Texas Health Science Center - Houston | Houston | Texas |
United States | Methodist Hospital | Indianapolis | Indiana |
United States | University of Miami Ryder Trauma Center | Miami | Florida |
United States | Hennepin County Medical Center | Minneapolis | Minnesota |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | San Antonio Military Medical Center (SAMMC) | San Antonio | Texas |
United States | University of Washington/Harborview Medical Center | Seattle | Washington |
United States | Wake Forest Baptist Medical Center | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Major Extremity Trauma Research Consortium |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Mortality | Any deaths that occur between index hospitalization and 30 days post-injury will be documented | 1 month | |
Primary | Blood products | We will document the volume of any blood products given within the first 24 hours following injury | 24 hours | |
Primary | Pelvic stabilization and resuscitative techniques | We will document any techniques used to stabilize and/or resuscitate the pelvic injury within the first 24 hours | 24 hours | |
Secondary | Blood loss | Total blood volume loss will be calculated within the first 24 hours following injury | 24 hours | |
Secondary | Ventilator days | Number of days that patient spends on a ventilator will be documented | 24 hours | |
Secondary | ICU days | Number of days spent in the ICU will be documented | 24 hours | |
Secondary | Length of hospital stay | Number of days spent in the hospital will be documented | 24 hours | |
Secondary | 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 | 24 hours |
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