Retroperitoneal Packing or Angioembolization for Hemorrhage Control of Pelvic Fractures

Not Applicable

Completed

• Conditions: Fractures, Bone; Multiple Trauma; Shock, Hemorrhagic
• Interventions: Procedure: ANGIO; Procedure: PACKING

• Registration Number: NCT02535624
• Lead Sponsor: Uppsala University

Brief 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?

Study Timeline

• Study Start: 2003-02
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Study First Submitted: 2015-08-05
• Study First Submitted QC: 2015-08-25
• Study First Posted: 2015-08-28
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-27
• Last Update Posted: 2017-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ANGIO	ANGIO	Patients with persistent hemodynamic instability (systolic blood pressure (SBP) \<90 mmHg after the transfusion of 4 packed red blood cell (PRBC) units in the emergency department) were taken urgently to the angiography suite for pelvic angiography. These patients had to tolerate transfer to the suite. Patients receiving primarily angioembolization therapy were defined as the ANGIO group.
PACKING	PACKING	Indication for pelvic packing was persistent SBP\<90 mmHg during the initial resuscitation period with 3000 ml of intravenous (IV) crystalloids and transfusion of 4 PRBC units. These patients were treated primarly with retroperitoneal packing, while angioembolization OR staff was unavailable (5pm-7am), and were defined as the PACK group.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of participants which required a secondary procedure (PACKING or ANGIO) after the primary intervention (PACKING or ANGIO)	participants will be followed for the duration of hospital stay, an expected average of 6 weeks	Packing for ANGIO and angioembolization for PACKING.
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
Days on ICU for each participant	participants will be followed for the duration of hospital stay, an expected average of 6 weeks
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
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
Procedural/surgical time (in minutes) for each participant	participants will be followed for the duration of hospital stay, an expected average of 6 weeks

Trial Locations

Locations (1)

Shandong Provincial Hospital; 🇨🇳 Jinan, Shandong, China