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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03977168
Other study ID # W81XWH-16-2-0060-EMS-BIND
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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