Clinical trial NCT02535624: Retroperitoneal Packing or Angioembolization for Hemorrhage Control of Pelvic Fractures
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shock, Hemorrhagic
Fractures, Bone
Multiple Trauma
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Shandong Provincial Hospital
First posted: 2015-08-28
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

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

Primary outcomes:
measure: Number of participants deceased occurring in-hospital during or after treatment with packing or embolization
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
measure: Number of postoperative packed red blood cell units administered for each participant
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
measure: Number of participants which required a secondary procedure (PACKING or ANGIO) after the primary intervention (PACKING or ANGIO)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
measure: Time from admission (in minutes) to treatment (PACKING or ANGIO) for each participant
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
measure: Procedural/surgical time (in minutes) for each participant
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
measure: Days on ICU for each participant
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
Study officials:
affiliation: Shandong Provincial Hospital
name: Dongsheng Zhou, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.