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OpenTrials
Completed

NCT Number: NCT03519594

The Size of Pelvic Hematoma Can be a Predictive Factor for Angioembolization

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.

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Key information

Conditions

Multiple Pelvic Fractures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Predictive factors for embolization in unstable pelvic fracture

    Time frame: 2 years

    The factors affecting embolization are analyzed by logistic regression analysis

Secondary outcomes

  1. The odds ratio of mortality rate between two groups

    Time frame: 2 years

    Obtain the difference in mortality rate between two groups

  2. Cut-off values of pelvic hematoma width

    Time frame: 2 years

    Measure the length of pelvic hematoma using the ROC curve

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

The Size of Pelvic Hematoma Can be a Predictive Factor for Angioembolization in Hemodynamically Unstable Pelvic Trauma

Important dates

Study start
2011
Primary completion
2013
Study completion
2017
First posted
May 9, 2018
Registry last updated
May 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.