Randomized Multicenter Study on the Management of Pelvic Fractures in Polytraumatized Patients With Hemodynamic Instability: Angioembolization vs Preperitoneal Packing
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Trauma
- Sponsor
- Nuria Llorach-Perucho
- Locations
- 1
- Primary Endpoint
- Pelvic bleeding control based on clinical response
- Status
- Withdrawn
- Last Updated
- 4 years ago
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.
Investigators
Nuria Llorach-Perucho
Principal Investigator
Corporacion Parc Tauli
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
Outcomes
Primary Outcomes
Pelvic bleeding control based on clinical response
Time Frame: 24 hours
Clinical response after the intervention
Secondary Outcomes
- Additional techniques(Through study completion, an average of 2 years)
- Post-procedure complications(Through study completion, an average of 2 years)
- Blood cell transfusion(Through study completion, an average of 2 years)
- Post-procedure complications degree(Through study completion, an average of 2 years)
- Time until intervention(Time until intervention (up to 60 minutes))
- Mortality(Through study completion, an average of 2 years)