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

NCT01958164 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2015-05-01

Study results available
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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

Interventions

DRUG

Actilyse

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

DRUG

Saline solution

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

DRUG

Actilyse

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

DRUG

Actilyse

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

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • Russia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01958164 on ClinicalTrials.gov