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

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.