NCT02492477

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Krankenhaus Barmherzige Schwestern Linz · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-07-08
• Last updated: 2018-08-21

Locations

1 site across 1 country: Austria