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

NCT03945045 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2022-08-17

No results posted yet for this study

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.

Conditions

  • Venous Thrombosis
  • Catheter-Related Infections
  • Catheter Mechanical Failure Rate

Interventions

PROCEDURE

Subclavian vein approach

Subclavian vein approach for Ultrasound-guided Implantation of TIVAD

PROCEDURE

internal jugular vein approach

internal jugular vein approach for Ultrasound-guided Implantation of TIVAD

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • CHENG-YUAN HSIEH, MD · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-21
Primary Completion
2024-01-31
Completion
2024-01-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03945045 on ClinicalTrials.gov