- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00755365
Intraoperative Angioembolization in the Management of Pelvic Fracture-Related Hemodynamic Instability
Study Overview
Status
Detailed Description
Pelvic fractures are not usually isolated injuries and it is common that these severely injured patients have concomitant abdominal or thoracic trauma further complicating their management. In situations where multiple sources of hemodynamic instability exist, the need to control hemorrhage quickly becomes imperative. In patients where emergent laparotomy or thoracotomy is indicated, the time until pelvic bleeding sources are addressed is prolonged. Some would argue that the best initial management of the pelvic fractures should be surgical stabilization, while others would support immediate angioembolization of actively bleeding pelvic vessels. The main drawback of angiographic embolization is that it occurs in a separate Angio Suite facility, with concerns being time lost to patient transport and an environment less capable of managing these extremely unstable patients.
At Hershey Medical Center, ten patients suffering pelvic fractures with associated hemodynamic instability between 2003 and 2007 were managed with intraoperative angioembolization (in the Operating Room as opposed to the Angio Suite). Extensive review of published orthopaedic, trauma surgery, and radiology journals yielded no other literature regarding intraoperative angioembolization as a management approach for these patients. Whether or not this approach has been carried out at other medical institutions, it is undoubtedly rare and results have yet to be reported in widely available literature. This novel approach has the potential to stop pelvic bleeding sooner and in a more controlled environment, where surgical stabilization can also be accomplished simultaneously. Statistical analysis and review of these patients has not been done, but may possibly show improvements in survival, shorter length of hospital stay, less time to embolization, and decreased need for supportive measures such as blood or platelet transfusion.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Penn State Milton S. Hershey Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with pelvic fractures and associated hemodynamic instability
- Treatment at Hershey Medical Center
- Patient management involved angioembolization in Operating Room
Exclusion Criteria:
- Patients below 18 years of age
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To present intraoperative angioembolization as a option in management of this group of patients and to describe the outcomes of these ten patients
Time Frame: 4 years
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4 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Soence Reid, MD, Milton S. Hershey Medical Center
Publications and helpful links
General Publications
- Agolini SF, Shah K, Jaffe J, Newcomb J, Rhodes M, Reed JF 3rd. Arterial embolization is a rapid and effective technique for controlling pelvic fracture hemorrhage. J Trauma. 1997 Sep;43(3):395-9. doi: 10.1097/00005373-199709000-00001.
- Balogh Z, King KL, Mackay P, McDougall D, Mackenzie S, Evans JA, Lyons T, Deane SA. The epidemiology of pelvic ring fractures: a population-based study. J Trauma. 2007 Nov;63(5):1066-73; discussion 1072-3. doi: 10.1097/TA.0b013e3181589fa4.
- Balogh Z, Caldwell E, Heetveld M, D'Amours S, Schlaphoff G, Harris I, Sugrue M. Institutional practice guidelines on management of pelvic fracture-related hemodynamic instability: do they make a difference? J Trauma. 2005 Apr;58(4):778-82. doi: 10.1097/01.ta.0000158251.40760.b2.
- Bassam D, Cephas GA, Ferguson KA, Beard LN, Young JS. A protocol for the initial management of unstable pelvic fractures. Am Surg. 1998 Sep;64(9):862-7.
- Fangio P, Asehnoune K, Edouard A, Smail N, Benhamou D. Early embolization and vasopressor administration for management of life-threatening hemorrhage from pelvic fracture. J Trauma. 2005 May;58(5):978-84; discussion 984. doi: 10.1097/01.ta.0000163435.39881.26.
- Miller PR, Moore PS, Mansell E, Meredith JW, Chang MC. External fixation or arteriogram in bleeding pelvic fracture: initial therapy guided by markers of arterial hemorrhage. J Trauma. 2003 Mar;54(3):437-43. doi: 10.1097/01.TA.0000053397.33827.DD.
- Sadri H, Nguyen-Tang T, Stern R, Hoffmeyer P, Peter R. Control of severe hemorrhage using C-clamp and arterial embolization in hemodynamically unstable patients with pelvic ring disruption. Arch Orthop Trauma Surg. 2005 Sep;125(7):443-7. doi: 10.1007/s00402-005-0821-7.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
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
- 28576EM
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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