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

Pelvic Fractures and Associated Hemodynamic Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00755365
• Other study ID #: 28576EM
• Status: Completed
• Start date: January 2003
• Est. completion date: November 21, 2019

Study information

• Verified date: November 2019
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 21, 2019
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• Pelvic Fractures and Associated Hemodynamic Instability

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

Agolini SF, Shah K, Jaffe J, Newcomb J, Rhodes M, Reed JF 3rd. Arterial embolization is a rapid and effective technique for controlling pelvic fracture hemorrhage. J Trauma. 1997 Sep;43(3):395-9. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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