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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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.
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.
Corporació Sanitària Parc Taulí
Sabadell, Barcelona, Spain
Pelvic bleeding control based on clinical response
Clinical response after the intervention
Time frame: 24 hours
Additional techniques
Need for additional techniques after the intervention to control bleeding associated with pelvic fracture
Time frame: Through study completion, an average of 2 years
Post-procedure complications
Presence of post-procedure complications
Time frame: Through study completion, an average of 2 years
Post-procedure complications degree
Description of post-procedure complications: Clavien Dindo scale
Time frame: Through study completion, an average of 2 years
Post-procedure complications degree
Description of post-procedure complications: Comprehensive Complication Index
Time frame: Through study completion, an average of 2 years
Mortality
Death of the pacient (cause and date)
Time frame: 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)
Time frame: Through study completion, an average of 2 years
Time until intervention
Time elapsed between hospital admission and intervention
Time frame: Time until intervention (up to 60 minutes)
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