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

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Vascular Access Devices; Catheter Obstruction

Treatments: Drug: Actilyse; Drug: Saline solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01958164

135.323

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Actilyse 2 mg/2 ml

Experimental group

Description:

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.

Treatment:

Drug: Actilyse

Drug: Actilyse

Drug: Actilyse

Saline solution (NaCl 0.9%)

Sham Comparator group

Description:

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.

Treatment:

Drug: Actilyse

Drug: Actilyse

Drug: Actilyse

Drug: Saline solution