Retroperitoneal Packing or Angioembolization for Hemorrhage Control of Pelvic Fractures

NCT ID: NCT02535624

Last Updated: 2017-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2013-02-28

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?

Conditions

Shock, Hemorrhagic; Fractures, Bone; Multiple Trauma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

ANGIO

Intervention Type: PROCEDURE

Using en endovascular approach, bleeding arteries are identified and clotted using embolizing agents, or coils.

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.

Group Type: ACTIVE_COMPARATOR

PACKING

Intervention Type: PROCEDURE

By retroperitoneal access the space in front of the pelvic fracture is compressed with surgical towels, which stops effectively venous bleeding

Interventions

PACKING

By retroperitoneal access the space in front of the pelvic fracture is compressed with surgical towels, which stops effectively venous bleeding

Intervention Type: PROCEDURE

ANGIO

Using en endovascular approach, bleeding arteries are identified and clotted using embolizing agents, or coils.

Intervention Type: PROCEDURE

Other Intervention Names

retroperitoneal pelvic packing; angioembolization

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role: collaborator

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dongsheng Zhou, MD, PhD

Role: STUDY_DIRECTOR

Shandong Provincial Hospital

Locations

Shandong Provincial Hospital

Jinan, Shandong, China

Countries

China

References

Li Q, Dong J, Yang Y, Wang G, Wang Y, Liu P, Robinson Y, Zhou D. Retroperitoneal packing or angioembolization for haemorrhage control of pelvic fractures--Quasi-randomized clinical trial of 56 haemodynamically unstable patients with Injury Severity Score >/=33. Injury. 2016 Feb;47(2):395-401. doi: 10.1016/j.injury.2015.10.008. Epub 2015 Oct 22.

Reference Type: DERIVED

PMID: 26508436 (View on PubMed)

Other Identifiers

PELVIC001

Identifier Type: -

Identifier Source: org_study_id