Central Venous Catheter ThrombosisNCT03766828
Dialysis Catheter Placement in Patients With Thoracic Central Venous Occlusion
An observational study of Central Venous Catheter Thrombosis, run by Medical University of Vienna at 1 site in Austria.
Trial summary
A unique inside-out-access technique with a new CE certified device (Surfacer (R) Bluegrass Vascular, San Antonio, Tx, USA) enables repetitive and confident right-sided placement of central venous catheters in hemodialysis patients with thoracic central venous occlusion. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Central Venous Catheter Thrombosis
- What is being tested?
- inside-out-access technique with inside-out access device (Surfacer (R)) and access technique including Sharp recanalization
- Type of treatment
- Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteAustria
- Study dates
- 1 Sep 2016to 30 Jun 2018
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hemodialysis patients with thoracic central venous occlusion requiring vascular access
Who may be able to join
- Patients with thoracic central venous occlusion
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna
Vienna, 1180
About this study
A unique inside-out-access technique with a new CE certified device (Surfacer (R) Bluegrass Vascular, San Antonio, Tx, USA) enables repetitive and confident right-sided placement of central venous catheters in hemodialysis patients with thoracic central venous occlusion.
- Conditions
- Central Venous Catheter Thrombosis
- Being tested
- inside-out-access technique with inside-out access device (Surfacer (R)), access technique including Sharp recanalization
- Keywords
- thoracic central venous occlusion, Dialysis access
- Medical subject headings
- Upper Extremity Deep Vein Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inside-out-access technique with inside-out access device (Surfacer (R))Procedure or surgery
inside-out-access technique with (Surfacer (R)) with a new CE certified device (Surfacer (R), Bluegrass Vascular)
access technique including Sharp recanalizationProcedure or surgery
access technique with Sharp recanalization via interventional radiology
| Study group | Role | What they receive |
|---|---|---|
| inside-out-access technique with inside-out access device | Not described Receives: Procedure: inside-out-access technique with inside-out access device (Surfacer (R)) | |
| access technique including Sharp recanalization | Not described Receives: Procedure: access technique including Sharp recanalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of dialysis access
Measured: 1 day
Secondary outcomes (1)
procedure related complications
infections, bleeding, hematoma or pericardial effusions and intervention related parameters
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start1 Sep 2016
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous Catheter ThrombosisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guerkan SENGOELGE, Medical University of Vienna
- Investigators
- Gürkan Sengölge, Principal investigator, Department of Medicine III, Division of Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766828
- Sponsor's protocol ID
- Vienna-DialysisAccess
- Status last verified
- May 2019
- First submitted
- 4 Dec 2018
- Last updated
- 29 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dialysis Catheter Placement in Patients With Thoracic Central Venous Occlusion
- ClinicalTrials.gov ID
- NCT03766828
- Acronym / sponsor ID
- Vienna-DialysisAccess
- Conditions
- Central Venous Catheter Thrombosis
- Keywords
- thoracic central venous occlusion, Dialysis access
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 6 Dec 2018 (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.
A unique inside-out-access technique with a new CE certified device (Surfacer (R) Bluegrass Vascular, San Antonio, Tx, USA) enables repetitive and confident right-sided placement of central venous catheters in hemodialysis patients with thoracic central venous occlusion.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inside-out-access technique with inside-out access device | – | Procedure: inside-out-access technique with inside-out access device (Surfacer (R)) |
| access technique including Sharp recanalization | – | Procedure: access technique including Sharp recanalization |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemodialysis patients with thoracic central venous occlusion requiring vascular access
Key inclusion criteria (1 listed)
- Patients with thoracic central venous occlusion
Key exclusion criteria (1 listed)
- pregnancy
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 |
|---|---|---|
| inside-out-access technique with inside-out access device (Surfacer (R))inside-out-access technique with (Surfacer (R)) with a new CE certified device (Surfacer (R), Bluegrass Vascular) | Procedure or surgery | inside-out-access technique with inside-out access device |
| access technique including Sharp recanalizationaccess technique with Sharp recanalization via interventional radiology | Procedure or surgery | access technique including Sharp recanalization |
Primary outcome
Achievement of dialysis access
Time frame: 1 day
1 secondary outcome
procedure related complications
Time frame: 3 months
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 29 May 2019.
Related trials for Central Venous Catheter Thrombosis
RecruitingPhase 3
Venous Thromboembolism (VTE) Prophylaxis With REGN7508 and REGN9933 in Adult and Adolescent Participants With a Peripherally Inserted Central Catheter (PICC)
Venous Thromboembolism (VTE)
Not yet recruitingObservational study
Efficacy and Safety of Peripherally Inserted Central Venous Catheters
Critical Illness, Catheter-Related Infections
Not yet recruiting
Comparison of the Best Method for Measuring Anti-Xa Activity in Children Receiving Unfractionated Heparin in Cardiac Intensive Care (COMPAXE-HNF)
Congenital Heart Disease, Unfractionated Heparin
RecruitingObservational study
Autopsy and Photon Counting Computed Tomography to Evaluate Thromboses Related to Central Venous Catheters
Central Venous Catheter Thrombosis
Recruiting
A Study of Cardiac Magnetic Resonance Imaging (CMR) for Evaluating Catheter-Associated Right Atrial Clot in People With Cancer
Adult Cancer Patients, Right Atrial Clot
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.
Gürkan Sengölge principal investigator
Department of Medicine III, Division of Nephrology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Venous Catheter Thrombosis, run by Medical University of Vienna at 1 site in Austria.
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 1 inclusion and 1 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 29 May 2019. 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 Austria. 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?
Achievement of dialysis access (time frame: 1 day). 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 29 May 2019.