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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03519594
Recruitment Status : Completed
First Posted : May 9, 2018
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Suk-Kyung, Asan Medical Center

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.

Condition or disease
Multiple Pelvic Fractures

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.

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Study Type : Observational
Actual Enrollment : 46 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Size of Pelvic Hematoma Can be a Predictive Factor for Angioembolization in Hemodynamically Unstable Pelvic Trauma
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : December 31, 2013
Actual Study Completion Date : May 1, 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Predictive factors for embolization in unstable pelvic fracture [ Time Frame: 2 years ]
    The factors affecting embolization are analyzed by logistic regression analysis


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with major trauma and pelvic bone fracture
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519594


Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Suk-kyung Hong, Ph.D. Asan Medical Center
Publications of Results:
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Responsible Party: Suk-Kyung, Associate professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03519594    
Other Study ID Numbers: AsanMC-Hematoma
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Suk-Kyung, Asan Medical Center:
angioembolization
computed tomography
Additional relevant MeSH terms:
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Hematoma
Hip Fractures
Hemorrhage
Pathologic Processes
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries