Intraoperative Angioembolization in the Management of Pelvic Fracture-Related Hemodynamic Instability
|ClinicalTrials.gov Identifier: NCT00755365|
Recruitment Status : Unknown
Verified September 2008 by Penn State University.
Recruitment status was: Active, not recruiting
First Posted : September 18, 2008
Last Update Posted : September 18, 2008
|Condition or disease|
|Pelvic Fractures and Associated Hemodynamic Instability|
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 :||Observational|
|Estimated Enrollment :||15 participants|
|Official Title:||Intraoperative Angioembolization in the Management of Pelvic Fracture-Related Hemodynamic Instability|
|Study Start Date :||January 2003|
|Actual Primary Completion Date :||December 2007|
|Estimated Study Completion Date :||September 2008|
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00755365
|United States, Pennsylvania|
|Penn State Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Soence Reid, MD||Milton S. Hershey Medical Center|