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

November 21, 2019 updated by: J. Spence Reid, Milton S. Hershey Medical Center
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

Study Overview

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

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S. Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Soence Reid, MD, Milton S. Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

November 21, 2019

Study Registration Dates

First Submitted

September 16, 2008

First Submitted That Met QC Criteria

September 17, 2008

First Posted (Estimate)

September 18, 2008

Study Record Updates

Last Update Posted (Actual)

November 22, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

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.

Clinical Trials on Pelvic Fractures and Associated Hemodynamic Instability

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