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Completed NCT03945045

A Study of the IJV or the SCV Approach for Ultrasound-guided Implantation of TIVAD

Conditions: Venous Thrombosis, Catheter-Related Infections, Catheter Mechanical Failure Rate

Sex: All
Ages: 20 Years – 99 Years
Healthy volunteers: No
Phase: NA
Enrollment: 201
Sponsor: National Taiwan University Hospital

Location: National Taiwan University Hospital Taipei Taipei

Summary

To compare IJV and SCV as the implantation site of TIVAD and its associated thrombotic or occlusion rate, our study plans to enroll 240 patients with cancer who require central line TIVADs and randomizes them with 1:1 ratio to receive the TIVAD implantation at SCV or IJV. After the implantation, the patients will be regularly followed through phone contact and chart review for 2 years, and any symptomatic thrombosis or occlusion will be found during chemotherapy injection or regular push-pull heparin saline flush every 6 weeks as our hospital care protocol. To detect any asymptomatic thrombosis, the patients will also receive screening vascular ultrasound at 2 weeks, 2 months, and 6 months postoperatively. The study primary endpoints include any infection, asymptomatic thrombosis found by screen ultrasound, and clinically symptomatic thrombosis or occlusion and major mechanical failure/dislocation of TIVAD.

Eligibility Criteria

Inclusion: 240 cancer patients, 20\~99 years old. Exclusion: 1. Breast cancer, mediastinal tumor above 6 cm, head and neck cancer with/without surgical/radiological treatment, lung tumor above 6 cm, 2. ECOG (Eastern Cooperative Oncology Group)performance status\>=2, can't tolerate sit-upright or standing postoperative chest plain film, 3. Allergy to prophylactic antibiotic, 4. History of previous TIVAD or Hickman catheter implantation. Recent 2 weeks Central venous catheter insertion. 5. End stage renal disease.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03945045). StuddyBuddy aggregates publicly available trial information.