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

Solid Tumours Clinical Trial

Official title:

TOP-TRIAL The Safety of Not Flushing the Non-used PORT-A-CATH® in Cancer Patients - a Prospective, Two-arm Phase I Trial, Pilot Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02492477
• Other study ID #: TOP-TRIAL-2014-1.2
• Status: Terminated
• Phase: Phase 1
• Start date: January 2016
• Est. completion date: July 2016

Study information

• Verified date: August 2018
• Source: Krankenhaus Barmherzige Schwestern Linz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Currently it is unknown if flushing a non-used PORT-A-CATH® every 4 weeks is a valid strategy to preserve its functioning. Even more, decision to keep the PORT-A-CATH® after completion of adjuvant therapy cannot be based on profound patient information as there exist hardly any data regarding PORT-A-CATH® related complications of non-used PORT-A-CATH®.

The proposed prospective, two arm trial aims to investigate if no flushing of a non-used PORT-A-CATH® over a period of one year has equal PORT-A-CATH® related complications compared to flushing the PORT-A-CATH® every 4 weeks.

The proposed trial also aims to examine the frequencies of PORT-A-CATH® related complications in non-used PORT-A-CATH®. The authors put up the hypothesis that there will be fewer port-a-cath related infections in the experimental arms compared to the infection rate mentioned in the literature up to 27 %, since the puncture of the PORT-A-CATH® and the administration of fluids are the main causes of infection.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Adjuvant Chemotherapy
• Flushing
• Port-A-Cath
• Solid Tumours

Intervention

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

Locations

Country	Name	City	State
Austria	Krankenhaus der Barmherzigen Schwerstern Linz Betriebsges.m.b.H.	Linz	Upper Austria

Sponsors (1)

Lead Sponsor	Collaborator
Krankenhaus Barmherzige Schwestern Linz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidences of PORT-A-CATH® related events (persistent malfunction, thrombosis, infection)		6 or 12 months
Secondary	incidences of restoration of PORT-A-CATH® function by alteplase		6 or 12 months
Secondary	rate of necessary PORT-A-CATH® removal		6 or 12 months