Efficacy and Safety of Actilyse 2 mg/ 2 ml in Comparison to Saline Solution in Patients With Central Venous Access Device Occlusion
Condition: Catheter Obstruction; Vascular Access Devices
Intervention: Actilyse; Saline solution; Actilyse; Actilyse
Intervention description: Actilyse 2mg/2ml will be given if the CVAD has not been restored at time 120min.; Instil Saline solution 2 ml into the disfunctional CVAD once at time O only for patients enrolled in Group II; Instil Actilyse 2 mg/ 2 ml into the dysfunctional CVAD at time O.; Second dose of Actilyse 2mg/2ml will be given if CVAD has not been restored at time 120min.
Intervention MeSH terms: Tissue Plasminogen Activator
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

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
    

Eligibility criteria:

        Inclusion criteria:

          -  Male and female patients between 18 and 80 years, who signed a written informed
             consent

          -  Patients with central venous access device occlusion, which occurred within 24-h
             before randomisation, where central venous access device is indicated for any of the
             following: fluid maintenance, chemotherapy, intravenous feeding, haemodialysis,
             long-term administration of antibiotics or other medication

          -  Patients with central venous access device occlusion occurred within 24-h before
             randomisation. Central venous access device is defined by inability to withdraw at
             least 3 ml of blood from the central venous access device. If multiple lumens are
             occluded, investigators are to choose and treat only one lumen for the study.

          -  Signed and dated written informed consent prior to admission to the study in
             accordance with good clinical practice and the local legislation. Acceptable level of
             the following laboratory parameters:

               -  hemoglobin ≥ 80 g/L;

               -  total white blood cell count ≥ 2.0 x109/L;

               -  platelets ≥ 50.0 x109/L;

               -  fibrinogen ≥0.5 x lower limit of normal;

               -  international normalized ratio <2 x upper limit of normal;

               -  activated partial thromboplastin time <2 x upper limit of normal;

               -  total protein ≥ 35 g/l;

               -  alanine transaminase <20 x upper limit of normal;

               -  aspartate transaminase <20 x upper limit of normal;

               -  total bilirubin <10 x upper limit of normal;

               -  creatinine <6 x upper limit of normal;

               -  glucose > 2.8 mmol/l.

        Exclusion criteria:

          -  Any clinical evidence of mechanical or non-thrombotic occlusion

          -  High risk for bleeding events

          -  High risk for embolic complications

          -  Any condition for which bleeding constitutes a significant hazard or would be
             particularly difficult to manage

          -  Administration of any fibrinolytic agent within 48 hours before start of study
             treatment

          -  Patients who have had any of the following within the previous 48 hours before start
             of study treatment:

               -  surgery

               -  obstetrical delivery

               -  percutaneous biopsy of viscera or deep tissues

               -  puncture of non-compressible vessels

               -  active internal bleeding

          -  Patients who have thrombocytopenia, other hemostatic defects (including those
             secondary to severe hepatic or renal disease).

          -  Pregnancy and lactation.

          -  Previously known positive results from infectious serology for Human Immunodeficiency
             Virus (HIV) or hepatitis B surface antigen (HBsAg), or hepatitis C virus.

          -  Known hypersensitivity to alteplase or gentamicin, or any excipient of Actilyse - Body
             weight <30 kg.

          -  Administration of any fibrinolytic agent within 48 hours before start of study
             treatment.

          -  Participation in another investigational trial within 30 days prior to the Screening
             Visit.

          -  Concomitant treatment with angiotensin-converting-enzyme inhibitors.

          -  Impossibility to infuse fluids at the volume necessary to infuse study drug (2 ml)
             into the central venous access device.