Pelvic Fractures in Polytraumatized Patients With Hemodynamic Instability: Angioembolization vs Preperitoneal Packing
- Conditions
- TraumaPelvic FractureHemodynamic Instability
- Interventions
- Procedure: AngioembolizationProcedure: Preperitoneal Pelvic Packing
- Registration Number
- NCT04764864
- Lead Sponsor
- Nuria Llorach-Perucho
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Systolic blood pressure ≤ 90 mmHg
- Heart rate > 100 bpm
- Shock Index ≥ 0,8
- Pelvic fracture
- Negative FAST / peritoneal aspiration
- Other causes of bleeding that require treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Angioembolization Angioembolization - Preperitoneal Pelvic Packing Preperitoneal Pelvic Packing -
- Primary Outcome Measures
Name Time Method Pelvic bleeding control based on clinical response 24 hours Clinical response after the intervention
- Secondary Outcome Measures
Name Time Method Additional techniques Through study completion, an average of 2 years Need for additional techniques after the intervention to control bleeding associated with pelvic fracture
Post-procedure complications Through study completion, an average of 2 years Presence of post-procedure complications
Blood cell transfusion Through study completion, an average of 2 years Need for blood cell transfusion for patients (number and need for masive transfusion protocol activation)
Post-procedure complications degree Through study completion, an average of 2 years Description of post-procedure complications: Comprehensive Complication Index
Time until intervention Time until intervention (up to 60 minutes) Time elapsed between hospital admission and intervention
Mortality Through study completion, an average of 2 years Death of the pacient (cause and date)
Trial Locations
- Locations (1)
Corporació Sanitària Parc Taulí
🇪🇸Sabadell, Barcelona, Spain