NCT02492477

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 8, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

6 months

First QC Date

June 29, 2015

Last Update Submit

August 19, 2018

Conditions

Adjuvant ChemotherapySolid TumoursPort-A-Cath

Outcome Measures

Primary Outcomes (1)

  • incidences of PORT-A-CATH® related events (persistent malfunction, thrombosis, infection)

    6 or 12 months

Secondary Outcomes (2)

  • incidences of restoration of PORT-A-CATH® function by alteplase

    6 or 12 months

  • rate of necessary PORT-A-CATH® removal

    6 or 12 months

Study Arms (2)

6 months

EXPERIMENTAL

evaluation of PORT-A-CATH®, blocking with Medunasal®-Heparinblock, restoration of PORT-A-CATH® with Alteplase

Procedure: evaluation of PORT-A-CATH®Drug: blocking with Medunasal®-HeparinblockDrug: restoration of PORT-A-CATH® with Alteplase

12 months

EXPERIMENTAL

evaluation of PORT-A-CATH®, blocking with Medunasal®-Heparinblock, restoration of PORT-A-CATH® with Alteplase

Procedure: evaluation of PORT-A-CATH®Drug: blocking with Medunasal®-HeparinblockDrug: restoration of PORT-A-CATH® with Alteplase

Interventions

evaluation of PORT-A-CATH®PROCEDURE

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

12 months6 months
blocking with Medunasal®-HeparinblockDRUG

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

Also known as: heparinized 0,9% NaCl solution
12 months6 months
restoration of PORT-A-CATH® with AlteplaseDRUG

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

Also known as: Actilyse®
12 months6 months

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cancer patients in curative setting, with port a cath Implantation for systemic chemotherapy, including neo-adjuvant and adjuvant chemo-immunotherapy and supportive therapy (e.g. parenteral Nutrition)
  • Completion of curative Treatment with port a cath indication, operation included, regardless of a non-intravenous (subcutaneous or oral) given therapy (endocrine therapy, chemo-immunotherapy, radiotherapy)
  • patients with pectoral port a cath systems
  • No port a cath associated complications during curative therapy such as investigated events: persistent malfunction, thrombosis, infection of the port-a-cath (to puncture the port a cath under X-ray control is allowed except it results in diangosis of persistent malfunction)
  • No therapeutic anticoagulant therapy (phenprocoumon/Marcoumar®, heparin)
  • No evidence of metastatic disease
  • ≥18 years
  • Willing to participate

You may not qualify if:

  • No signed informed consent
  • Patients with port a cath systems other than pectoral port a cath systems (e.g. forearm port a cath System)
  • Unable to attend control timepoints
  • Use of the port-a-cath after the above defined curative treatment (within the investigational period)
  • Willing to explant the port-a-cath
  • Willing to become pregnant within one year after adjuvant treatment
  • Patient with heparin-induced Thrombocytopenia (HIT)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Krankenhaus der Barmherzigen Schwerstern Linz Betriebsges.m.b.H.

Linz, Upper Austria, 4010, Austria

Location

MeSH Terms

Interventions

Tissue Plasminogen Activator

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBiological Factors

Study Officials

  • Judith Lafleur, OA Dr.

    BHSL, Abt. für Gynäkologie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2015

First Posted

July 8, 2015

Study Start

January 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 21, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)