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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Penn State University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00755365
First received: September 16, 2008
Last updated: September 17, 2008
Last verified: September 2008
  Purpose

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


Condition
Pelvic Fractures and Associated Hemodynamic Instability

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Intraoperative Angioembolization in the Management of Pelvic Fracture-Related Hemodynamic Instability

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: January 2003
Estimated Study Completion Date: September 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755365

Locations
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Penn State University
Investigators
Principal Investigator: Soence Reid, MD Milton S. Hershey Medical Center
  More Information

Publications:
Responsible Party: J. Spence Reid, M.D., Penn State Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00755365     History of Changes
Other Study ID Numbers: 28576EM
Study First Received: September 16, 2008
Last Updated: September 17, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
pelvic fractures
angioembolism
Treatment at Hershey Medical Center
Angioembolization in Operating Room

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014