Clinical trial NCT00755365: Intraoperative Angioembolization in the Management of Pelvic Fracture-Related Hemodynamic Instability
Official title: Intraoperative Angioembolization in the Management of Pelvic Fracture-Related Hemodynamic Instability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Fractures and Associated Hemodynamic Instability
Keywords: pelvic fractures
angioembolism
Treatment at Hershey Medical Center
Angioembolization in Operating Room
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2008-09-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects in this study are trauma patients over 18 years of age who suffered pelvic fractures and developed associated hemodynamic instability between January 1, 2003 and December 31, 2007. All patients were treated at Hershey Medical Center and received intraoperative angioembolization as a part of their medical management.

Brief summary: Mortality associated with pelvic fractures resulting from blunt trauma ranges between 6 and 18%. In cases where hemodynamic instability is also present, the mortality rate is significantly greater, and has been reported as high as 60%. There is no general consensus among traumatologists as to the initial management of this complicated subgroup of patients. It is largely debated whether emergent orthopedic fixation or angiographic embolization should be the first line of treatment for pelvic hemorrhage

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.

Eligibility criteria: 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

Primary outcomes:
measure: To present intraoperative angioembolization as a option in management of this group of patients and to describe the outcomes of these ten patients
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Soence Reid, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.