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

Major Extremity Trauma Research Consortium600 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

600

Conditions

Pelvic Fracture

Interventions

Application of circumferential pelvic compression (CPC) devicePROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Blood products

We will document the volume of any blood products given within the first 24 hours following injury

Time frame: 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

Time frame: 24 hours

Secondary Outcomes

Blood loss

Total blood volume loss will be calculated within the first 24 hours following injury

Time frame: 24 hours

Ventilator days

Number of days that patient spends on a ventilator will be documented

Time frame: 24 hours

ICU days

Number of days spent in the ICU will be documented

Time frame: 24 hours

Length of hospital stay

Number of days spent in the hospital will be documented

Time frame: 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

Time frame: 24 hours

Data from ClinicalTrials.gov

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