Conditions: Catheter Obstruction Vascular Access Devices
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 16
Healthy volunteers: no

Brief 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

Detailed description:

Arms:
arm 1: First dose of Actilyse 2mg/2ml will be given at time 0. Second dose will be given at 120 if CVAD function has not been restored. arm 2: Saline solution will be given at time 0. First dose of Actilyse 2mg/2ml will be given to patients if CVAD function has not been restored.

Interventions: intervention 1: Actilyse intervention 2: Saline solution intervention 3: Actilyse intervention 4: Actilyse
Intervention descriptions: intervention 1: Actilyse 2mg/2ml will be given if the CVAD has not been restored at time 120min. intervention 2: Instil Saline solution 2 ml into the disfunctional CVAD once at time O only for patients enrolled in Group II intervention 3: Instil Actilyse 2 mg/ 2 ml into the dysfunctional CVAD at time O. intervention 4: Second dose of Actilyse 2mg/2ml will be given if CVAD has not been restored at time 120min.

Protocol document: