Multiple Pelvic FracturesNCT03519594
The Size of Pelvic Hematoma Can be a Predictive Factor for Angioembolization
An observational study of Multiple Pelvic Fractures, run by Asan Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Pelvic Fractures
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 1 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with major trauma and pelvic bone fracture
Who may be able to join
- patients with shock (systolic blood pressure <90 mmHg) arrived at a single hospital within 24 h after injury after pelvic fracture
Who cannot join
- declared dead on arrival
- patients with other organ injuries
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Pelvic Fractures
- Keywords
- angioembolization, computed tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Embolization group | The group that underwent embolization after pelvic injury. | |
| Non-embolization group | The observed group of pelvic injuries without embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive factors for embolization in unstable pelvic fracture
The factors affecting embolization are analyzed by logistic regression analysis
Measured: 2 years
Secondary outcomes (2)
The odds ratio of mortality rate between two groups
Obtain the difference in mortality rate between two groups
Measured: 2 years
Cut-off values of pelvic hematoma width
Measure the length of pelvic hematoma using the ROC curve
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start1 Jan 2011
- Primary completion31 Dec 2013
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple Pelvic FracturesStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suk-Kyung, Asan Medical Center
- Investigators
- Suk-kyung Hong, Ph.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519594
- Sponsor's protocol ID
- AsanMC-Hematoma
- Status last verified
- May 2018
- First submitted
- 20 Apr 2018
- Last updated
- 9 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28115984Hymel 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.
PubMed 28463936Salim 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.
PubMed 18954776Blackmore 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.
PubMed 16917449
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Size of Pelvic Hematoma Can be a Predictive Factor for Angioembolization in Hemodynamically Unstable Pelvic Trauma
- ClinicalTrials.gov ID
- NCT03519594
- Acronym / sponsor ID
- AsanMC-Hematoma
- Conditions
- Multiple Pelvic Fractures
- Keywords
- angioembolization, computed tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 9 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Embolization group | – | –The group that underwent embolization after pelvic injury. |
| Non-embolization group | – | –The observed group of pelvic injuries without embolization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with major trauma and pelvic bone fracture
Key inclusion criteria (1 listed)
- patients with shock (systolic blood pressure <90 mmHg) arrived at a single hospital within 24 h after injury after pelvic fracture
Key exclusion criteria (2 listed)
- declared dead on arrival
- patients with other organ injuries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictive factors for embolization in unstable pelvic fracture
Time frame: 2 years
The factors affecting embolization are analyzed by logistic regression analysis
2 secondary outcomes
The odds ratio of mortality rate between two groups
Time frame: 2 years
Cut-off values of pelvic hematoma width
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
- Results publication: PubMed 28115984Coccolini 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.
- Results publication: PubMed 28463936Hymel 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.
- Results publication: PubMed 18954776Salim 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.
- Results publication: PubMed 16917449Blackmore 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suk-kyung Hong, Ph.D. principal investigator
Asan Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Pelvic Fractures, run by Asan Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive factors for embolization in unstable pelvic fracture (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03519594, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2018.