NCT04764864

Pelvic Fractures in Polytraumatized Patients With Hemodynamic Instability: Angioembolization vs Preperitoneal Packing

Withdrawn NA Last updated 19 January 2022

What this trial tests

NA trial testing Angioembolization in Trauma. Withdrawn.

Timeline

1 January 2022

Primary endpoint
1 January 2022

1 January 2022

Quick facts

Lead sponsor	Nuria Llorach-Perucho
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Start date	1 January 2022
Primary completion	1 January 2022
Estimated completion	1 January 2022
Sites	1 location across Spain

Drugs / interventions tested

• Angioembolization
• Preperitoneal Pelvic Packing

Conditions studied

• Trauma — all drugs for Trauma →
• Pelvic Fracture — all drugs for Pelvic Fracture →
• Hemodynamic Instability — all drugs for Hemodynamic Instability →

Sponsor

Nuria Llorach-Perucho

Who can join

18 and older, any sex, with Trauma or Pelvic Fracture. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.