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A Prospective Study of Early Mechanical Stabilization and Bleeding in Disruption of the Pelvic Ring | Clinical Trials | Clareo Health

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

NCT03977168•Major Extremity Trauma Research Consortium

View on ClinicalTrials.gov

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

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

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

Locations (11)

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

Key Dates

Start Date

May 17, 2019

Primary Completion Date

June 30, 2022

Completion Date

September 1, 2022

Last Updated

August 30, 2022

Enrollment

600

ESTIMATED participants

Conditions

Pelvic Fracture

Interventions

Application of circumferential pelvic compression (CPC) device

PROCEDURE

Developing a Decision Instrument to Guide Abdominal-pelvic CT Imaging of Blunt Trauma Patients

NCT04937868

Abdominal InjuryPelvic Fracture+12 more

View study

RECRUITINGNA

Geriatric Lateral Compression 1 Pelvic Fractures

NCT05765669

Lateral Compression 1 Pelvic Fracture

View study

COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 30, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Developing a Decision Instrument to Guide Abdominal-pelvic CT Imaging of Blunt Trauma Patients

Geriatric Lateral Compression 1 Pelvic Fractures

Incidence of Venous Thromboembolism in Patients With Pelvic and Acetabular Fractures (PAF)

A Retrospective Cohort Study of 15 Cases of Pelvic Fractures Complicated by Morel-Lavallee Lesion

Clinical Outcome and Fusion Results Using the SiJoin® Transfixing Sacroiliac Fusion Device

Intraoperative Angioembolization in the Management of Pelvic Fracture-Related Hemodynamic Instability