Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): poor recruitment
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adjuvant Chemotherapy | — | UNRESOLVED | — |
| Port-A-Cath | — | UNRESOLVED | — |
| Solid Tumours | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blocking with Medunasal®-Heparinblock | Drug | — | UNRESOLVED |
| evaluation of PORT-A-CATH® | Procedure | — | UNRESOLVED |
| restoration of PORT-A-CATH® with Alteplase | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 6 months
- description
- evaluation of PORT-A-CATH®, blocking with Medunasal®-Heparinblock, restoration of PORT-A-CATH® with Alteplase
- interventionNames
- Procedure: evaluation of PORT-A-CATH®
- Drug: blocking with Medunasal®-Heparinblock
- Drug: restoration of PORT-A-CATH® with Alteplase
- type
- EXPERIMENTAL
- label
- 12 months
- description
- evaluation of PORT-A-CATH®, blocking with Medunasal®-Heparinblock, restoration of PORT-A-CATH® with Alteplase
- interventionNames
- Procedure: evaluation of PORT-A-CATH®
- Drug: blocking with Medunasal®-Heparinblock
- Drug: restoration of PORT-A-CATH® with Alteplase
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available