Retroperitoneal Packing or Angioembolization for Hemorrhage Control of Pelvic Fractures

Study Overview
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Brief Summary
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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
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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?

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

Conditions
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Shock, Hemorrhagic, Fractures, Bone, Multiple Trauma

Intervention / Treatment
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* Procedure: PACKING
* Procedure: ANGIO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |