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NCT02492477
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
Phase 1 trial testing evaluation of PORT-A-CATH® in Adjuvant Chemotherapy in 4 participants. Terminated before completion.
1 July 2016
Quick facts
| Lead sponsor | Krankenhaus Barmherzige Schwestern Linz |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 4 |
| Start date | 1 January 2016 |
| Primary completion | 1 July 2016 |
| Estimated completion | 1 July 2016 |
| Sites | 1 location across Austria |
Drugs / interventions tested
- evaluation of PORT-A-CATH®
- blocking with Medunasal®-Heparinblock — full drug profile →
- restoration of PORT-A-CATH® with Alteplase — full drug profile →
Conditions studied
- Adjuvant Chemotherapy — all drugs for Adjuvant Chemotherapy →
- Solid Tumours — all drugs for Solid Tumours →
- Port-A-Cath — all drugs for Port-A-Cath →
Sponsor
Krankenhaus Barmherzige Schwestern Linz — full company profile →
Who can join
Adults 18 to 90, any sex, with Adjuvant Chemotherapy or Solid Tumours. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
incidences of PORT-A-CATH® related events (persistent malfunction, thrombosis, infection)
Time frame: 6 or 12 months
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02492477
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02492477 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Krankenhaus Barmherzige Schwestern Linz
- Last refreshed: 19 August 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02492477.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing