A Prospective Study of Early Mechanical Stabilization and Bleeding in Disruption of the Pelvic Ring

Status unconfirmed

Conditions studied: Pelvic Fracture

In brief

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).

Key facts

Study ID

NCT03977168

Run by

Major Extremity Trauma Research Consortium

People needed

600

Starts

2019-05-17

Expected to finish

2022-09-01

Last updated by the study team

2022-08-30

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Miami Ryder Trauma Center — Miami, Florida, United States
• Methodist Hospital — Indianapolis, Indiana, United States
• University of Maryland R Adams Cowley Shock Trauma Center — Baltimore, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Texas Health Science Center - Houston — Houston, Texas, United States
• San Antonio Military Medical Center (SAMMC) — San Antonio, Texas, United States
• University of Washington/Harborview Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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