Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00755365
Recruitment Status : Completed
First Posted : September 18, 2008
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
J. Spence Reid, 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

Condition or disease
Pelvic Fractures and Associated Hemodynamic Instability

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Intraoperative Angioembolization in the Management of Pelvic Fracture-Related Hemodynamic Instability
Study Start Date : January 2003
Actual Primary Completion Date : December 2007
Actual Study Completion Date : November 21, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00755365


Locations
Layout table for location information
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Soence Reid, MD Milton S. Hershey Medical Center
Publications:
Layout table for additonal information
Responsible Party: J. Spence Reid, Principal Investigator, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00755365    
Other Study ID Numbers: 28576EM
First Posted: September 18, 2008    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019
Keywords provided by J. Spence Reid, Milton S. Hershey Medical Center:
pelvic fractures
angioembolism
Treatment at Hershey Medical Center
Angioembolization in Operating Room
Additional relevant MeSH terms:
Layout table for MeSH terms
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries