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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-17

Study Completion Date

2022-09-30

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).

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Detailed Description

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Conditions

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Pelvic Fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Application of circumferential pelvic compression (CPC) device

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

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No