A Prospective Study of Early Mechanical Stabilization and Bleeding in Disruption of the Pelvic Ring (EMS-BIND)

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Pelvic Fracture
• Intervention / Treatment: Procedure: Application of circumferential pelvic compression (CPC) device

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Ryder Trauma Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Methodist Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland R Adams Cowley Shock Trauma Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center - Houston
    • San Antonio, Texas, United States, 78234
      • San Antonio Military Medical Center (SAMMC)
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington/Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with severe pelvic ring disruptions

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood products	We will document the volume of any blood products given within the first 24 hours following injury	24 hours
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss	Total blood volume loss will be calculated within the first 24 hours following injury	24 hours
Ventilator days	Number of days that patient spends on a ventilator will be documented	24 hours
ICU days	Number of days spent in the ICU will be documented	24 hours
Length of hospital stay	Number of days spent in the hospital will be documented	24 hours
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Any deaths that occur between index hospitalization and 30 days post-injury will be documented	1 month

Collaborators and Investigators

• Sponsor: Major Extremity Trauma Research Consortium

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2019
• Primary Completion (Actual): June 30, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: June 4, 2019
• First Submitted That Met QC Criteria: June 4, 2019
• First Posted (Actual): June 6, 2019

Study Record Updates

• Last Update Posted (Actual): August 30, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures
• Other Study ID Numbers: W81XWH-16-2-0060-EMS-BIND

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No