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

Pelvic Fracture Clinical Trial

— EMS-BIND  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03977168
• Other study ID #: W81XWH-16-2-0060-EMS-BIND
• Status: Enrolling by invitation
• Start date: May 17, 2019
• Est. completion date: September 2022

Study information

• Verified date: August 2022
• Source: Major Extremity Trauma Research Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 600
• Est. completion date: September 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Fractures
• Pelvic Fracture

Intervention

Procedure:
• Application of circumferential pelvic compression (CPC) device
Application of circumferential pelvic compression (CPC) device used at any time within 24 hours of injury

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Major Extremity Trauma Research Consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality	Any deaths that occur between index hospitalization and 30 days post-injury will be documented	1 month
Primary	Blood products	We will document the volume of any blood products given within the first 24 hours following injury	24 hours
Primary	Pelvic stabilization and resuscitative techniques	We will document any techniques used to stabilize and/or resuscitate the pelvic injury within the first 24 hours	24 hours
Secondary	Blood loss	Total blood volume loss will be calculated within the first 24 hours following injury	24 hours
Secondary	Ventilator days	Number of days that patient spends on a ventilator will be documented	24 hours
Secondary	ICU days	Number of days spent in the ICU will be documented	24 hours
Secondary	Length of hospital stay	Number of days spent in the hospital will be documented	24 hours
Secondary	GCS (Glascow Coma Score)	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	24 hours