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

Study Overview
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Brief Summary
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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).

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

Conditions
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Pelvic Fracture

Intervention / Treatment
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* Procedure: Application of circumferential pelvic compression (CPC) device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Application of circumferential pelvic compression (CPC) device|Application of circumferential pelvic compression (CPC) device used at any time within 24 hours of injury|

What is the study measuring?
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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 |