A Prospective Study of Early Mechanical Stabilization and Bleeding in Disruption of the Pelvic Ring
- Conditions
- Pelvic Fracture
- Registration Number
- NCT03977168
- Lead Sponsor
- Major Extremity Trauma Research Consortium
- Brief 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, angioembolization, REBOA).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 600
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood products 24 hours We will document the volume of any blood products given within the first 24 hours following injury
Pelvic stabilization and resuscitative techniques 24 hours We will document any techniques used to stabilize and/or resuscitate the pelvic injury within the first 24 hours
- Secondary Outcome Measures
Name Time Method Ventilator days 24 hours Number of days that patient spends on a ventilator will be documented
ICU days 24 hours Number of days spent in the ICU will be documented
Blood loss 24 hours Total blood volume loss will be calculated within the first 24 hours following injury
Length of hospital stay 24 hours Number of days spent in the hospital will be documented
GCS (Glascow Coma Score) 24 hours 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
Trial Locations
- Locations (11)
University of Maryland R Adams Cowley Shock Trauma Center
🇺🇸Baltimore, Maryland, United States
University of Miami Ryder Trauma Center
🇺🇸Miami, Florida, United States
University of Washington/Harborview Medical Center
🇺🇸Seattle, Washington, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
University of Texas Health Science Center - Houston
🇺🇸Houston, Texas, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
Wake Forest Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
San Antonio Military Medical Center (SAMMC)
🇺🇸San Antonio, Texas, United States