Clinical trial NCT03977168: A Prospective Study of Early Mechanical Stabilization and Bleeding in Disruption of the Pelvic Ring
Official title: A Prospective Study of Early Mechanical Stabilization and Bleeding in Disruption of the Pelvic Ring
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Fracture
Lead sponsor: Major Extremity Trauma Research Consortium
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe pelvic ring disruptions

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).


Eligibility criteria: 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

Primary outcomes:
measure: Blood products
timeFrame: 24 hours
measure: Pelvic stabilization and resuscitative techniques
timeFrame: 24 hours
Secondary outcomes:
measure: Blood loss
timeFrame: 24 hours
measure: Ventilator days
timeFrame: 24 hours
measure: ICU days
timeFrame: 24 hours
measure: Length of hospital stay
timeFrame: 24 hours
measure: GCS (Glascow Coma Score)
timeFrame: 24 hours
Other outcomes:
measure: Mortality
timeFrame: 1 month
Locations:
city: Miami
country: United States
facility: University of Miami Ryder Trauma Center
state: Florida
city: Indianapolis
country: United States
facility: Methodist Hospital
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland R Adams Cowley Shock Trauma Center
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: University of Texas Health Science Center - Houston
state: Texas
city: San Antonio
country: United States
facility: San Antonio Military Medical Center (SAMMC)
state: Texas
city: Seattle
country: United States
facility: University of Washington/Harborview Medical Center
state: Washington
Study officials:
References: