- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03519594
The Size of Pelvic Hematoma Can be a Predictive Factor for Angioembolization
The Size of Pelvic Hematoma Can be a Predictive Factor for Angioembolization in Hemodynamically Unstable Pelvic Trauma
Study Overview
Status
Conditions
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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Investigators
- Principal Investigator: Suk-kyung Hong, Ph.D., Asan Medical Center
Publications and helpful links
General Publications
- Coccolini F, Stahel PF, Montori G, Biffl W, Horer TM, Catena F, Kluger Y, Moore EE, Peitzman AB, Ivatury R, Coimbra R, Fraga GP, Pereira B, Rizoli S, Kirkpatrick A, Leppaniemi A, Manfredi R, Magnone S, Chiara O, Solaini L, Ceresoli M, Allievi N, Arvieux C, Velmahos G, Balogh Z, Naidoo N, Weber D, Abu-Zidan F, Sartelli M, Ansaloni L. Pelvic trauma: WSES classification and guidelines. World J Emerg Surg. 2017 Jan 18;12:5. doi: 10.1186/s13017-017-0117-6. eCollection 2017.
- Hymel A, Asturias S, Zhao F, Bliss R, Moran T, Marshall RH, Benjamin E, Phelan HA, Krause PC, Marecek GS, Leonardi C, Stuke L, Hunt JP, Mooney JL. Selective versus nonselective embolization versus no embolization in pelvic trauma: A multicenter retrospective cohort study. J Trauma Acute Care Surg. 2017 Sep;83(3):361-367. doi: 10.1097/TA.0000000000001554.
- Salim A, Teixeira PG, DuBose J, Ottochian M, Inaba K, Margulies DR, Demetriades D. Predictors of positive angiography in pelvic fractures: a prospective study. J Am Coll Surg. 2008 Nov;207(5):656-62. doi: 10.1016/j.jamcollsurg.2008.05.025. Epub 2008 Jul 14.
- Blackmore CC, Cummings P, Jurkovich GJ, Linnau KF, Hoffer EK, Rivara FP. Predicting major hemorrhage in patients with pelvic fracture. J Trauma. 2006 Aug;61(2):346-52. doi: 10.1097/01.ta.0000226151.88369.c9.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AsanMC-Hematoma
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.