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

Not Applicable

Withdrawn

• Conditions: Trauma; Pelvic Fracture; Hemodynamic Instability

• Registration Number: NCT04764864
• Lead Sponsor: Nuria Llorach-Perucho

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-02-18
• Study First Posted: 2021-02-21
• Status Verified: 2022-01
• Study Start: 2022-01-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01
• Last Update Submitted: 2022-01-04
• Last Update Posted: 2022-01-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pelvic bleeding control based on clinical response	24 hours	Clinical response after the intervention

Secondary Outcome Measures

Name	Time	Method
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
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
Mortality	Through study completion, an average of 2 years	Death of the pacient (cause and date)
Post-procedure complications degree	Through study completion, an average of 2 years	Description of post-procedure complications: Comprehensive Complication Index

Trial Locations

Locations (1)

Corporació Sanitària Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain