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

Study Timeline

• Study Start: 2019-05-17
• Study First Submitted: 2019-06-04
• Study First Submitted QC: 2019-06-04
• Study First Posted: 2019-06-06
• Primary Completion: 2022-06-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-29
• Last Update Posted: 2022-08-30
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

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 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

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