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

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.

Study Overview

• Status: Completed
• Conditions: Fractures, Bone; Shock, Hemorrhagic; Multiple Trauma
• Intervention / Treatment: Procedure: ANGIO; Procedure: PACKING

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250021
      • Shandong Provincial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: ANGIO; Using en endovascular approach, bleeding arteries are identified and clotted using embolizing agents, or coils.; Other Names: angioembolization
Active Comparator: 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.	Procedure: PACKING; By retroperitoneal access the space in front of the pelvic fracture is compressed with surgical towels, which stops effectively venous bleeding; Other Names: retroperitoneal pelvic packing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Procedural/surgical time (in minutes) for each participant		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

Collaborators and Investigators

• Sponsor: Uppsala University
• Collaborators: Shandong Provincial Hospital
• Investigators: Study Director: Dongsheng Zhou, MD, PhD, Shandong Provincial Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2003
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: August 5, 2015
• First Submitted That Met QC Criteria: August 25, 2015
• First Posted (Estimate): August 28, 2015

Study Record Updates

• Last Update Posted (Actual): October 30, 2017
• Last Update Submitted That Met QC Criteria: October 27, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Leg Injuries; Shock; Femoral Fractures; Hip Injuries; Hemorrhage; Fractures, Bone; Hip Fractures; Shock, Hemorrhagic; Multiple Trauma
• Other Study ID Numbers: PELVIC001