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| Name | Class |
|---|---|
| Corporacion Parc Tauli | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Angioembolization | Active Comparator |
| |
| Preperitoneal Pelvic Packing | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angioembolization | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pelvic bleeding control based on clinical response | Clinical response after the intervention | 24 hours |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time until arrival at hospital | Time elapsed between prehospital attention and hospital admission | Time until arrival at hospital (up to 30 minutes) |
| Duration of angioembolization | Duration of angioembolization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nuria Llorach-Perucho, MD | Corporacion Parc Tauli | Principal Investigator |
| Salvador Navarro-Soto, MD, PhD | Corporacion Parc Tauli | Study Director |
| Andrea Campos-Serra, MD | Corporacion Parc Tauli | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corporació Sanità ria Parc Taulà | Sabadell | Barcelona | 08208 | Spain |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D006620 | Hip Fractures |
| D012769 | Shock |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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| Preperitoneal Pelvic Packing | Procedure | 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. |
|
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) |
| Through study completion, an average of 2 years |
| Angioembolization treatment | Arteries treated with angioembolization | Through study completion, an average of 2 years |
| Duration of Preperitoneal Pelvic Packing | Duration of Preperitoneal Pelvic Packing | Through study completion, an average of 2 years |
| Intensive care unit stay | Number of days that the patient remains in the intensive care unit | Through study completion, an average of 2 years |
| Hospital stay | Number of days that the patient remains in hospital | Through study completion, an average of 2 years |
| Readmission | Readmission 30 days after discharge | 30 days after discharge |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |