Pelvic Fractures in Polytraumatized Patients With Hemodynamic Instability: Angioembolization vs Preperitoneal Packing

Study Overview
=================
Brief Summary
-----------------
Pelvic fracture is a usual injury in trauma patients. An unstable trauma patient with a pelvic fracture has an elevated risk of death due to pelvic bleeding and the associated injuries. Traditionally, it has been estimated that the main source of bleeding is venous and, consequently, the main treatment has been the preperitoneal pelvic packing. Nevertheless, according to new data, arterial bleeding appears to be a more important source of pelvic bleeding than it was thought and angioembolization seems to be a good alternative in the treatment of these injuries. Consequently, it is important to define better the management of these patients. This investigation project consists in a clinical trial study, performed by a multidisciplinary team of many hospitals around the country, in which angioembolization and preperitoneal pelvic packing are compared. Unstable trauma patients with a pelvic fracture and no other injuries (negative FAST / peritoneal aspiration, no evidence of bone fractures or thoracic injuries) will be submitted, in less than 60 minutes from hospital arrival, to angioembolization or preperitoneal pelvic packing, according to randomization. There will be a specific timing evaluation of different markers: hemodynamic (vital signs at arrival, immediately and 24 hours after treatment) and analytic (at arrival and upon entering to the Intensive Care Unit). Registered variables include: blood cell transfusions, vasoactive drug requirements, time elapsed between hospital admission and intervention, treatment duration, need of other strategies to stop pelvic bleeding, complications and mortality. The objective of this study is to determinate if angioembolization is superior to preperitoneal pelvic packing for pelvic bleeding control in unstable trauma patients due to pelvic bleeding.

Official Title
-----------------
Randomized Multicenter Study on the Management of Pelvic Fractures in Polytraumatized Patients With Hemodynamic Instability: Angioembolization vs Preperitoneal Packing

Conditions
-----------------
Trauma, Pelvic Fracture, Hemodynamic Instability

Intervention / Treatment
-----------------
* Procedure: Angioembolization
* Procedure: Preperitoneal Pelvic Packing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Systolic blood pressure ≤ 90 mmHg Heart rate > 100 bpm Shock Index ≥ 0,8 Pelvic fracture Negative FAST / peritoneal aspiration Exclusion Criteria: Other causes of bleeding that require treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Angioembolization<br> | Procedure: Angioembolization<br>* Via the femoral route, a non-selective pelvic arteriography with a selective embolization of the arterial branches that show direct or indirect signs of injury will be performed. In the event of persistent hemodynamic instability after selective embolization, non-selective bilateral embolization of the internal iliac arteries will be evaluated. The material used will vary depending on the characteristics of the injury and the availability of the materials.<br>|
| Active Comparator: Preperitoneal Pelvic Packing<br> | Procedure: Preperitoneal Pelvic Packing<br>* Pfannestiel incision / infraumbilical laparotomy. Dissection of tissues up to and including the transversalis fascia. Inferior to this and anterior to the peritoneum, the preperitoneal cavity is identified. Inclusion of radiopaque laparotomy gauze in each hemipelvis, from the posterior part (anterior to the sacro-iliac joint) to the most anterior in the retropubic position. Subsequently, the closure is carried out to increase the plugging effect. A second intervention is required to remove the material in 24-48 hours.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic bleeding control based on clinical response | Clinical response after the intervention | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional techniques | Need for additional techniques after the intervention to control bleeding associated with pelvic fracture | Through study completion, an average of 2 years | 
| Post-procedure complications | Presence of post-procedure complications | Through study completion, an average of 2 years | 
| Post-procedure complications degree | Description of post-procedure complications: Clavien Dindo scale | Through study completion, an average of 2 years | 
| Post-procedure complications degree | Description of post-procedure complications: Comprehensive Complication Index | Through study completion, an average of 2 years | 
| Mortality | Death of the pacient (cause and date) | Through study completion, an average of 2 years | 
| Blood cell transfusion | Need for blood cell transfusion for patients (number and need for masive transfusion protocol activation) | Through study completion, an average of 2 years | 
| Time until intervention | Time elapsed between hospital admission and intervention | Time until intervention (up to 60 minutes) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trauma, Pelvis Fracture, Hypovolemic Shock, Preperitoneal Pelvic Packing, Angioembolization, Hemodynamic Instability