NCT01958164

Efficacy and Safety of Actilyse 2 mg/ 2 ml in Comparison to Saline Solution in Patients With Central Venous Access Device Occlusion

A Multicenter, Open-label, Randomised, Clinical Trial to Compare the Efficacy and Safety of Actilyse 2 mg/ 2 ml Versus Saline Solution in Restoring Function of an Occluded Central Venous Access Device

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a multicentre, open-label, randomised, phase III study designed to evaluate the efficacy and safety of Actilyse 2 mg/2 ml in the restoration of function of CVAD

Conditions

• Catheter Obstruction
• Vascular Access Devices

Interventions

Type	Name	Description
DRUG	Actilyse	Actilyse 2mg/2ml will be given if the CVAD has not been restored at time 120min.
DRUG	Saline solution	Instil Saline solution 2 ml into the disfunctional CVAD once at time O only for patients enrolled in Group II
DRUG	Actilyse	Instil Actilyse 2 mg/ 2 ml into the dysfunctional CVAD at time O.
DRUG	Actilyse	Second dose of Actilyse 2mg/2ml will be given if CVAD has not been restored at time 120min.

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2013-10-09
• Last updated: 2015-05-01
• Results posted: 2015-05-01

Locations

5 sites across 1 country: Russia