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

May 7, 2018 updated by: Suk-Kyung, Asan Medical Center

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

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.

Study Overview

Status

Completed

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.

Study Type

Observational

Enrollment (Actual)

46

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with major trauma and pelvic bone fracture

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Embolization group
The group that underwent embolization after pelvic injury.
Non-embolization group
The observed group of pelvic injuries without embolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive factors for embolization in unstable pelvic fracture
Time Frame: 2 years
The factors affecting embolization are analyzed by logistic regression analysis
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The odds ratio of mortality rate between two groups
Time Frame: 2 years
Obtain the difference in mortality rate between two groups
2 years
Cut-off values of pelvic hematoma width
Time Frame: 2 years
Measure the length of pelvic hematoma using the ROC curve
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Suk-kyung Hong, Ph.D., Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

December 31, 2013

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

April 20, 2018

First Submitted That Met QC Criteria

May 7, 2018

First Posted (Actual)

May 9, 2018

Study Record Updates

Last Update Posted (Actual)

May 9, 2018

Last Update Submitted That Met QC Criteria

May 7, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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