Clinical trial NCT03519594: The Size of Pelvic Hematoma Can be a Predictive Factor for Angioembolization
Official title: The Size of Pelvic Hematoma Can be a Predictive Factor for Angioembolization in Hemodynamically Unstable Pelvic Trauma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Pelvic Fractures
Keywords: angioembolization
computed tomography
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2018-05-09
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with major trauma and pelvic bone fracture

Brief summary: Unstable pelvic fracture with bleeding can be fatal, with a mortality rate of up to 40%. Therefore, early detection and treatment are important in unstable pelvic trauma. We investigated the early predictive factors for possible embolization in patients with hemodynamically unstable pelvic trauma. The purpose of this study was to predict the necessity of embolization and the timing of angiography using CT scans.

Detailed description: Background: Unstable pelvic fracture with bleeding can be fatal, with a mortality rate of up to 40%. Therefore, early detection and treatment are important in unstable pelvic trauma. We investigated the early predictive factors for possible embolization in patients with hemodynamically unstable pelvic trauma.

Methods: From January 2011 to December 2013, 46 patients with shock arrived at a single hospital within 24 h after injury. Of them, 44 patients underwent computed tomography (CT) after initial resuscitation, except for 2 who were dead on arrival. Nine patients with other organ injuries were excluded. Seventeen patients underwent embolization. A single radiologist measured the width (longest length in axial view) and length (longest length in coronal view) of pelvic hematoma on CT scans. Demographic, clinical, and radiological data were reviewed retrospectively.

Eligibility criteria: Inclusion Criteria:

* patients with shock (systolic blood pressure \<90 mmHg) arrived at a single hospital within 24 h after injury after pelvic fracture

Exclusion Criteria:

* declared dead on arrival
* patients with other organ injuries

Primary outcomes:
measure: Predictive factors for embolization in unstable pelvic fracture
timeFrame: 2 years
Secondary outcomes:
measure: The odds ratio of mortality rate between two groups
timeFrame: 2 years
measure: Cut-off values of pelvic hematoma width
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Asan Medical Center
name: Suk-kyung Hong, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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