Retroperitoneal Packing or Angioembolization for Hemorrhage Control of Pelvic Fractures

Fractures, Bone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02535624
• Other study ID #: PELVIC001
• Status: Completed
• Phase: N/A
• First received: August 5, 2015
• Last updated: October 27, 2017
• Start date: February 2003
• Est. completion date: February 2013

Study information

• Verified date: October 2017
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• multitrauma defined as Injury Severity Score (ISS) > 17

• dislocated pelvic fracture type B or C according to Tile[10] on emergency department pelvic radiograph

• hemodynamic instability defined as systolic blood pressure (SBP) <90 mmHg after administration of 4 units of packed red blood cells (PRBC).

Exclusion Criteria:

• monotrauma, or ISS = 17

• age > 65 years

• age < 18 years

Related Conditions & MeSH terms

• Fractures, Bone
• Hemorrhage
• Hip Fractures
• Multiple Trauma
• Shock, Hemorrhagic

Intervention

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

Locations

Country	Name	City	State
China	Shandong Provincial Hospital	Jinan	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Shandong Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants deceased occurring in-hospital during or after treatment with packing or embolization		participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Secondary	Number of postoperative packed red blood cell units administered for each participant		participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Secondary	Number of participants which required a secondary procedure (PACKING or ANGIO) after the primary intervention (PACKING or ANGIO)	Packing for ANGIO and angioembolization for PACKING.	participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Secondary	Time from admission (in minutes) to treatment (PACKING or ANGIO) for each participant		participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Secondary	Procedural/surgical time (in minutes) for each participant		participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Secondary	Days on ICU for each participant		participants will be followed for the duration of hospital stay, an expected average of 6 weeks