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

NCT ID: NCT00755365

Last Updated: 2019-11-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2019-11-21

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.

Conditions

Pelvic Fractures and Associated Hemodynamic Instability

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

J. Spence Reid

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Soence Reid, MD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 9314298 (View on PubMed)

Balogh Z, King KL, Mackay P, McDougall D, Mackenzie S, Evans JA, Lyons T, Deane SA. The epidemiology of pelvic ring fractures: a population-based study. J Trauma. 2007 Nov;63(5):1066-73; discussion 1072-3. doi: 10.1097/TA.0b013e3181589fa4.

Reference Type: BACKGROUND

PMID: 17993952 (View on PubMed)

Balogh Z, Caldwell E, Heetveld M, D'Amours S, Schlaphoff G, Harris I, Sugrue M. Institutional practice guidelines on management of pelvic fracture-related hemodynamic instability: do they make a difference? J Trauma. 2005 Apr;58(4):778-82. doi: 10.1097/01.ta.0000158251.40760.b2.

Reference Type: BACKGROUND

PMID: 15824655 (View on PubMed)

Bassam D, Cephas GA, Ferguson KA, Beard LN, Young JS. A protocol for the initial management of unstable pelvic fractures. Am Surg. 1998 Sep;64(9):862-7.

Reference Type: BACKGROUND

PMID: 9731815 (View on PubMed)

Fangio P, Asehnoune K, Edouard A, Smail N, Benhamou D. Early embolization and vasopressor administration for management of life-threatening hemorrhage from pelvic fracture. J Trauma. 2005 May;58(5):978-84; discussion 984. doi: 10.1097/01.ta.0000163435.39881.26.

Reference Type: BACKGROUND

PMID: 15920412 (View on PubMed)

Miller PR, Moore PS, Mansell E, Meredith JW, Chang MC. External fixation or arteriogram in bleeding pelvic fracture: initial therapy guided by markers of arterial hemorrhage. J Trauma. 2003 Mar;54(3):437-43. doi: 10.1097/01.TA.0000053397.33827.DD.

Reference Type: BACKGROUND

PMID: 12634521 (View on PubMed)

Sadri H, Nguyen-Tang T, Stern R, Hoffmeyer P, Peter R. Control of severe hemorrhage using C-clamp and arterial embolization in hemodynamically unstable patients with pelvic ring disruption. Arch Orthop Trauma Surg. 2005 Sep;125(7):443-7. doi: 10.1007/s00402-005-0821-7.

Reference Type: BACKGROUND

PMID: 15977021 (View on PubMed)

Other Identifiers

28576EM

Identifier Type: -

Identifier Source: org_study_id