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Clinical Trials/NCT04764864
NCT04764864
Withdrawn
Not Applicable

Randomized Multicenter Study on the Management of Pelvic Fractures in Polytraumatized Patients With Hemodynamic Instability: Angioembolization vs Preperitoneal Packing

Nuria Llorach-Perucho1 site in 1 countryJanuary 1, 2022

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Withdrawn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.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
January 1, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Nuria Llorach-Perucho
Responsible Party
Sponsor Investigator
Principal Investigator

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)

Study Sites (1)

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