Hemodynamic Instability, Pelvic Fracture, Trauma
Conditions
Keywords
Trauma, Pelvis Fracture, Hypovolemic Shock, Preperitoneal Pelvic Packing, Angioembolization, Hemodynamic Instability
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.
Interventions
PROCEDUREAngioembolization
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.
PROCEDUREPreperitoneal Pelvic Packing
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.
Sponsors
Corporacion Parc Tauli
Nuria Llorach-Perucho
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic bleeding control based on clinical response | 24 hours | Clinical response after the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Post-procedure complications degree | Through study completion, an average of 2 years | Description of post-procedure complications: Clavien Dindo scale |
| Mortality | Through study completion, an average of 2 years | Death of the pacient (cause and date) |
| 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) |
| Time until intervention | Time until intervention (up to 60 minutes) | Time elapsed between hospital admission and intervention |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time until arrival at hospital | Time until arrival at hospital (up to 30 minutes) | Time elapsed between prehospital attention and hospital admission |
| Duration of angioembolization | Through study completion, an average of 2 years | Duration of angioembolization |
| Angioembolization treatment | Through study completion, an average of 2 years | Arteries treated with angioembolization |
| Duration of Preperitoneal Pelvic Packing | Through study completion, an average of 2 years | Duration of Preperitoneal Pelvic Packing |
| Intensive care unit stay | Through study completion, an average of 2 years | Number of days that the patient remains in the intensive care unit |
| Hospital stay | Through study completion, an average of 2 years | Number of days that the patient remains in hospital |
| Readmission | 30 days after discharge | Readmission 30 days after discharge |
Countries
Spain
Outcome results
None listed