NCT02535624

Retroperitoneal Packing or Angioembolization for Hemorrhage Control of Pelvic Fractures

Retroperitoneal Packing or Angioembolization for Hemorrhage Control of Pelvic Fractures - Quasi-randomized Clinical Trial of 56 Hemodynamically Unstable Patients With Injury Severity Score ≥ 33

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to answer whether minimal invasive vessel clotting (angioembolization) or open surgery (retroperitoneal packing) is more effective for pelvic fractures with massive bleeding. Patients admitted at daytime (7am-5pm) are treated with angioembolization while patients admitted at nighttime (5pm to 7am) are treated with open surgery.

Detailed description

In patients with pelvic fracture uncontrollable bleeding is the major cause of death within the first 24h after injury. Early hemorrhage control is therefore vital for successful treatment. Nowadays, recommended techniques for hemorrhage control in pelvic fractures are retroperitoneal pelvic packing and angioembolization, dependent upon the available technical staff and resources and the condition of the patient. Retroperitoneal pelvic packing, on the one hand, is a relatively simple method in controlling pelvic hemorrhage even with limited resources. Since 89% of pelvic fracture hemorrhage originates from venous bleeding, fracture stabilization and compressive hemostasis by packing is a reasonable approach. Angioembolization, on the other hand, has great high effectiveness with regard to bleeding control, but requires an angiography suite and technical staff. Since hemostasis of retroperitoneal venous bleeding often can be achieved by external pelvic fixation, angioembolization is required for the 11% arterial bleedings which are hard to control by packing. Even though many authors see both methods as complements, time is crucial in the multitrauma setting and the severely injured patient does not tolerate multiple interventions well. Until now good predictors for treatment choice are unavailable, and management of hemodynamically unstable pelvic fractures remains a matter of debate. This study was designed to answer following questions: * Is retroperitoneal pelvic packing or angiography superior with regard to in-hospital mortality, complications, required secondary procedures, or post-intervention blood loss? * Which of these methods is the more rapid intervention in the acute setting?

Conditions

• Shock, Hemorrhagic
• Fractures, Bone
• Multiple Trauma

Interventions

Type	Name	Description
PROCEDURE	PACKING	By retroperitoneal access the space in front of the pelvic fracture is compressed with surgical towels, which stops effectively venous bleeding
PROCEDURE	ANGIO	Using en endovascular approach, bleeding arteries are identified and clotted using embolizing agents, or coils.

Timeline

• Start date: 2003-02-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2015-08-28
• Last updated: 2017-10-30

Locations

1 site across 1 country: China