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

Multiple Pelvic Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03519594
• Other study ID #: AsanMC-Hematoma
• Status: Completed
• Start date: January 1, 2011
• Est. completion date: May 1, 2017

Study information

• Verified date: May 2018
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 1, 2017
• Est. primary completion date: December 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematoma
• Hip Fractures
• Multiple Pelvic Fractures

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

References & Publications (4)

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. — View Citation

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 — View Citation

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 retrospect — View Citation

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 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive factors for embolization in unstable pelvic fracture	The factors affecting embolization are analyzed by logistic regression analysis	2 years
Secondary	The odds ratio of mortality rate between two groups	Obtain the difference in mortality rate between two groups	2 years
Secondary	Cut-off values of pelvic hematoma width	Measure the length of pelvic hematoma using the ROC curve	2 years