Venous ThrombosisNCT03945045
A Study of the IJV or the SCV Approach for Ultrasound-guided Implantation of TIVAD
A study testing Subclavian vein approach and internal jugular vein approach in people with Venous Thrombosis and Catheter-Related Infections, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Venous Thrombosis, Catheter-Related Infections, Catheter Mechanical Failure Rate
- What is being tested?
- Subclavian vein approach and internal jugular vein approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 May 2019to 7 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Breast cancer, mediastinal tumor above 6 cm, head and neck cancer with/without surgical/radiological treatment, lung tumor above 6 cm,
- ECOG (Eastern Cooperative Oncology Group)performance status>=2, can't tolerate sit-upright or standing postoperative chest plain film,
- Allergy to prophylactic antibiotic,
- History of previous TIVAD or Hickman catheter implantation. Recent 2 weeks Central venous catheter insertion.
- End stage renal disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study of the Internal Jugular Vein or the Subclavian Vein Approach for Ultrasound-guided Implantation of Totally Implantable Vascular Access Device(TIVAD)
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.
Read the detailed description
A totally implantable venous access device (TIVAD) provides reliable, long-term vascular access and improves cancer patients' quality of life. The use of TIVADs is associated with important complications as infection and venous thrombosis, and studies have shown that several factors are associated, such as cancer types, catheter types, and the location of the catheter tips. Whether subclavian vein(SCV)or internal jugular vein(IJV) is a better site for TIVAD percutaneous access were also widely studied, and there is no definite consensus generated yet.
A meta-analysis published in 2016 by Wu et al reviewed 12 studies comparing the internal jugular vein (IJV) with the subclavian vein (SCV) as the percutaneous access site found no differences of TIVAD-related infection and catheter-related thrombotic rate. In the secondary outcome, IJV was associated with reduced risks of total major mechanical complications such as catheter dislocation and malfunction. Of 12 studies included, only 3 were randomized trial and there was no consistency between groups of using ultrasound guidance throughout TIVAD insertion. To be further, there is no description of how close to IJV-SCV junction does IJV group were inserted. Hence, a large well-designed RCT is warranted before the IJV site can be recommended.
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.
- Being tested
- Subclavian vein approach, internal jugular vein approach
- Keywords
- venous thrombosis
- Medical subject headings
- Venous Thrombosis, Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subclavian vein approachProcedure or surgery
Also called SCV
Subclavian vein approach for Ultrasound-guided Implantation of TIVAD
internal jugular vein approachProcedure or surgery
Also called IJV
internal jugular vein approach for Ultrasound-guided Implantation of TIVAD
| Study group | Role | What they receive |
|---|---|---|
| SCV | Experimental | TIVAD implanted through subclavian vein under real-time ultrasound guidance Receives: Procedure: Subclavian vein approach |
| IJV | Experimental | TIVAD implanted through internal jugular vein under real-time ultrasound guidance Receives: Procedure: internal jugular vein approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
infection (blood stream or local wound)
- catheter-related blood stream infection(CRBSI) due to TIVAD, including: 1-1. at least one positive blood culture obtained from a peripheral vein, clinical manifestations of infections (i.e., fever, chills, and/or hypotension), and no apparent source for the blood stream infection, except the TIVAD, which leads to the TIVAD removal. Subsequent TIVAD catheter tip culture yields the same organism. 1-2. Differential time to positivity, with blood culture drawn from the TIVAD that becomes positive at least 2 hr earlier than the peripheral blood culture.
- TIVAD local wound infection and/or non-healing will be classified as infection.
Measured: 2 years
asymptomatic venous thrombosis
- asymptomatic venous thrombosis found by study initiated screening ultrasound at 2 weeks, 2 months, and 6 months postoperatively.
- asymptomatic venous thrombosis found by chart review of chest CT/plain film, if exams are available due to other medical indication within 2 years postoperatively.
Measured: 2 years
symptomatic venous thrombosis with positive confirmatory image tests
both positive symptoms and positive confirmative image tests should be met.
Positive symptom noted by the patient or caregiver, such as
- any arm swelling or swelling sensation
- suspicious pulmonary embolism with symptom as dyspnea, chest tightness/pain, Hemoptysis...etc.
Positive confirmatory image tests as
- vascular sonography
- Catheter-based angiography
- Computed tomographic pulmonary angiography (CTPA) or magnetic resonance pulmonary angiography (MRPA)
- Ventilation perfusion (V/Q) scanning when pulmonary embolism is suspected.
Measured: 2 years
TIVAD catheter occlusion
Failure or difficult to infuse fluid or withdraw blood from TIVAD. Difficult to withdraw blood from TIVAD in certain body position is not counted.
Measured: 2 years
major mechanical failure, dislocation of TIVAD.
- catheter kinking, looping, migration to different vessel
- catheter disintegration from port.
Measured: 2 years
Secondary outcomes (1)
Intolerable pain or foreign body sensation of TIVAD
- Subjectively, intolerable "pain or foreign body sensation" of TIVAD, which leads to TIVAD remove without other medical reasons.
- Patient requests for TIVAD remove with no pain, no foreign body sensation, and no other medical reasons will not be included in the measure. (that is, "I want to remove TIVAD because TIVAD is an implant")
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start21 May 2019
- Primary completion25 Jan 2024
- Study completion7 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CHENG-YUAN HSIEH, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945045
- Sponsor's protocol ID
- 201807144RINC
- Status last verified
- Jul 2026
- First submitted
- 5 May 2019
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of the Internal Jugular Vein or the Subclavian Vein Approach for Ultrasound-guided Implantation of Totally Implantable Vascular Access Device(TIVAD)
- ClinicalTrials.gov ID
- NCT03945045
- Acronym / sponsor ID
- 201807144RINC
- Keywords
- venous thrombosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 21 May 2019 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 7 Jul 2025 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A totally implantable venous access device (TIVAD) provides reliable, long-term vascular access and improves cancer patients' quality of life. The use of TIVADs is associated with important complications as infection and venous thrombosis, and studies have shown that several factors are associated, such as cancer types, catheter types, and the location of the catheter tips. Whether subclavian vein(SCV)or internal jugular vein(IJV) is a better site for TIVAD percutaneous access were also widely studied, and there is no definite consensus generated yet.
A meta-analysis published in 2016 by Wu et al reviewed 12 studies comparing the internal jugular vein (IJV) with the subclavian vein (SCV) as the percutaneous access site found no differences of TIVAD-related infection and catheter-related thrombotic rate. In the secondary outcome, IJV was associated with reduced risks of total major mechanical complications such as catheter dislocation and malfunction. Of 12 studies included, only 3 were randomized trial and there was no consistency between groups of using ultrasound guidance throughout TIVAD insertion. To be further, there is no description of how close to IJV-SCV junction does IJV group were inserted. Hence, a large well-designed RCT is warranted before the IJV site can be recommended.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCV | Experimental | Procedure: Subclavian vein approachTIVAD implanted through subclavian vein under real-time ultrasound guidance |
| IJV | Experimental | Procedure: internal jugular vein approachTIVAD implanted through internal jugular vein under real-time ultrasound guidance |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Breast cancer, mediastinal tumor above 6 cm, head and neck cancer with/without surgical/radiological treatment, lung tumor above 6 cm,
- ECOG (Eastern Cooperative Oncology Group)performance status>=2, can't tolerate sit-upright or standing postoperative chest plain film,
- Allergy to prophylactic antibiotic,
- History of previous TIVAD or Hickman catheter implantation. Recent 2 weeks Central venous catheter insertion.
- End stage renal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subclavian vein approachAlso: SCVSubclavian vein approach for Ultrasound-guided Implantation of TIVAD | Procedure or surgery | SCV |
| internal jugular vein approachAlso: IJVinternal jugular vein approach for Ultrasound-guided Implantation of TIVAD | Procedure or surgery | IJV |
Primary outcome
infection (blood stream or local wound)
Time frame: 2 years
1. catheter-related blood stream infection(CRBSI) due to TIVAD, including: 1-1. at least one positive blood culture obtained from a peripheral vein, clinical manifestations of infections (i.e., fever, chills, and/or hypotension), and no apparent source for the blood stream infection, except the TIVAD, which leads to the TIVAD removal. Subsequent TIVAD catheter tip culture yields the same organism. 1-2. Differential time to positivity, with blood culture drawn from the TIVAD that becomes positive at least 2 hr earlier than the peripheral blood culture. 2. TIVAD local wound infection and/or non-healing will be classified as infection.
asymptomatic venous thrombosis
Time frame: 2 years
1. asymptomatic venous thrombosis found by study initiated screening ultrasound at 2 weeks, 2 months, and 6 months postoperatively. 2. asymptomatic venous thrombosis found by chart review of chest CT/plain film, if exams are available due to other medical indication within 2 years postoperatively.
symptomatic venous thrombosis with positive confirmatory image tests
Time frame: 2 years
both positive symptoms and positive confirmative image tests should be met. Positive symptom noted by the patient or caregiver, such as 1. any arm swelling or swelling sensation 2. suspicious pulmonary embolism with symptom as dyspnea, chest tightness/pain, Hemoptysis...etc. Positive confirmatory image tests as 1. vascular sonography 2. Catheter-based angiography 3. Computed tomographic pulmonary angiography (CTPA) or magnetic resonance pulmonary angiography (MRPA) 4. Ventilation perfusion (V/Q) scanning when pulmonary embolism is suspected.
TIVAD catheter occlusion
Time frame: 2 years
Failure or difficult to infuse fluid or withdraw blood from TIVAD. Difficult to withdraw blood from TIVAD in certain body position is not counted.
major mechanical failure, dislocation of TIVAD.
Time frame: 2 years
1. catheter kinking, looping, migration to different vessel 2. catheter disintegration from port.
1 secondary outcome
Intolerable pain or foreign body sensation of TIVAD
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CHENG-YUAN HSIEH, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subclavian vein approach and internal jugular vein approach in people with Venous Thrombosis and Catheter-Related Infections, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infection (blood stream or local wound) (time frame: 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.