Intraoperative Angioembolization in the Management of Pelvic Fracture-Related Hemodynamic Instability

Completed

• Conditions: Pelvic Fractures and Associated Hemodynamic Instability

• Registration Number: NCT00755365
• Lead Sponsor: Milton S. Hershey Medical Center

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.

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2007-12
• Study First Submitted: 2008-09-16
• Study First Submitted QC: 2008-09-17
• Study First Posted: 2008-09-18
• Status Verified: 2019-11
• Study Completion: 2019-11-21
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To present intraoperative angioembolization as a option in management of this group of patients and to describe the outcomes of these ten patients	4 years

Trial Locations

Locations (1)

Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States