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TOP-TRIAL Safety of Not Flushing Non-used PORT-A-CATH® in Cancer Patients

NCT02492477 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2018-08-21

No results posted yet for this study

Summary

The benefits and risks of flushing or not flushing the non-used PORT-A-CATH® in cancer patients and the time interval of eventual PORT-A-CATH® flushing are currently unknown. The manufacturers of PORT-A-CATH® recommend regular flushings every 4 weeks. In clinical practice, the intervals are usually at least three months. Regular flushing might lead to a decreased risk of PORT-A-CATH® thrombosis, but may also lead to an increased infection or thrombosis rate and patients discomfort. Therefore, this study investigates the safety of not flushing the PORT-A-CATH® for 6 or 12 months.

Conditions

Interventions

PROCEDURE

evaluation of PORT-A-CATH®

in patients in curative setting, clinical assessment, PORT-A-CATH® testing of possibility of saline-administration and blood withdrawal with vacutainer, laboratory assessment

DRUG

blocking with Medunasal®-Heparinblock

blocking of the functioning PORT-A-CATH® with heparinized 0,9% NaCl solution

DRUG

restoration of PORT-A-CATH® with Alteplase

by malfunction of the PORT-A-CATH® attempting of restoration with Actilyse® according to guidelines

Sponsors & Collaborators

  • Krankenhaus Barmherzige Schwestern Linz

    lead OTHER

Principal Investigators

  • Judith Lafleur, OA Dr. · BHSL, Abt. für Gynäkologie

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Austria

Study Locations

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Entities

Diseases

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 NCT02492477 on ClinicalTrials.gov