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

NCT ID: NCT01958164

Last Updated: 2015-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-04-30

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

Conditions

Catheter Obstruction; Vascular Access Devices

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Actilyse 2 mg/2 ml

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.

Group Type: EXPERIMENTAL

Actilyse

Intervention Type: DRUG

Instil Actilyse 2 mg/ 2 ml into the dysfunctional CVAD at time O.

Actilyse

Intervention Type: DRUG

Second dose of Actilyse 2mg/2ml will be given if CVAD has not been restored at time 120min.

Saline solution (NaCl 0.9%)

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.

Group Type: SHAM_COMPARATOR

Actilyse

Intervention Type: DRUG

Actilyse 2mg/2ml will be given if the CVAD has not been restored at time 120min.

Saline solution

Intervention Type: DRUG

Instil Saline solution 2 ml into the disfunctional CVAD once at time O only for patients enrolled in Group II

Interventions

Actilyse

Actilyse 2mg/2ml will be given if the CVAD has not been restored at time 120min.

Intervention Type: DRUG

Saline solution

Instil Saline solution 2 ml into the disfunctional CVAD once at time O only for patients enrolled in Group II

Intervention Type: DRUG

Actilyse

Instil Actilyse 2 mg/ 2 ml into the dysfunctional CVAD at time O.

Intervention Type: DRUG

Actilyse

Second dose of Actilyse 2mg/2ml will be given if CVAD has not been restored at time 120min.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

135.323.1 Boehringer Ingelheim Investigational Site

Akhangelsk, , Russia

135.323.2 Boehringer Ingelheim Investigational Site

Krasnodar, , Russia

135.323.3 Boehringer Ingelheim Investigational Site

Krasnoyarsk, , Russia

135.323.7 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

135.323.5 Boehringer Ingelheim Investigational Site

Samara, , Russia

Countries

Russia

Other Identifiers

135.323

Identifier Type: -

Identifier Source: org_study_id