ThrombosisNCT01988766
Risk of Central Venous Stenosis in Patients With Chronic Renal Failure After IJ Line Placement
An observational study of Thrombosis, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to compare the difference in thrombosis as a result of internal jugular (IJ) catheters versus peripherally inserted central catheter (PICC) lines. It is hypothesized that there will be a decreased rate of thrombosis in patients as a result of IJ catheters verses PICC lines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombosis
- How many people
- 1,424 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Aug 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who had a PICC line placed at the University of Chicago by the procedure service between September 1, 2010 and December 31, 2011
Who may be able to join
- subjects who had a PICC line placed at the University of Chicago between September 1, 2010 and December 31, 2011
Who cannot join
- subjects under the age of 18
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the difference in thrombosis as a result of internal jugular (IJ) catheters versus peripherally inserted central catheter (PICC) lines. It is hypothesized that there will be a decreased rate of thrombosis in patients as a result of IJ catheters verses PICC lines.
Read the detailed description
In a cohort of patients from Sept 1, 2010 until December 31, 2011 with chronic kidney disease (CKD) has shown that the incidence of IJ thrombosis after short term catheter access occurred in only 1/26 subjects or 4%. The current study is being done to compare this experience with the incidence of thrombosis from PICC lines. A secondary aim will be to determine if variables such as level of renal function, prior history of thrombosis or atherosclerosis contribute to the risk of thrombosis when PICC lines are placed. This data will provide the first comparison of the incidence of thrombotic complications from short term IJ catheter access versus PICC lines.
- Conditions
- Thrombosis
- Keywords
- Thrombosis, Central Venosis Catheter, Renal Disease, Vascular Access
- Medical subject headings
- Thrombosis, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Thrombosis | incidence of thrombosis in subjects who had PICC line placement | |
| No Thrombosis | no incidence of thrombosis in subjects who had PICC line placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Thrombosis
To calculate the incidence of deep venous thrombosis from PICC lines in patients
Measured: 15 months
Secondary outcomes (1)
Demographic Risk Factor Association with Risk of Thrombosis from PICC or IJ access
To evaluate if factors, known to be associated with thrombosis and atherosclerosis, are associated with the risk of thrombosis from PICC or IJ access. These factors include: renal failure, diabetes, hypertension, cancer, transplant, gender, age or the indication for the access, including antibiotics or chemotherapy.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startOct 2012
- Primary completionSep 2013
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- 1,424 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary Hammes, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988766
- Sponsor's protocol ID
- IRB12-1889
- Status last verified
- Nov 2014
- First submitted
- 13 Nov 2013
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Central Venous Stenosis in Patients With Chronic Renal Failure After IJ Line Placement
- ClinicalTrials.gov ID
- NCT01988766
- Acronym / sponsor ID
- IRB12-1889
- Conditions
- Thrombosis
- Keywords
- Thrombosis, Central Venosis Catheter, Renal Disease, Vascular Access
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,424 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 20 Nov 2013 (estimated)
- 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.
The purpose of this study is to compare the difference in thrombosis as a result of internal jugular (IJ) catheters versus peripherally inserted central catheter (PICC) lines. It is hypothesized that there will be a decreased rate of thrombosis in patients as a result of IJ catheters verses PICC lines.
Detailed description
In a cohort of patients from Sept 1, 2010 until December 31, 2011 with chronic kidney disease (CKD) has shown that the incidence of IJ thrombosis after short term catheter access occurred in only 1/26 subjects or 4%. The current study is being done to compare this experience with the incidence of thrombosis from PICC lines. A secondary aim will be to determine if variables such as level of renal function, prior history of thrombosis or atherosclerosis contribute to the risk of thrombosis when PICC lines are placed. This data will provide the first comparison of the incidence of thrombotic complications from short term IJ catheter access versus PICC lines.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thrombosis | – | –incidence of thrombosis in subjects who had PICC line placement |
| No Thrombosis | – | –no incidence of thrombosis in subjects who had PICC line placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who had a PICC line placed at the University of Chicago by the procedure service between September 1, 2010 and December 31, 2011
Key inclusion criteria (1 listed)
- subjects who had a PICC line placed at the University of Chicago between September 1, 2010 and December 31, 2011
Key exclusion criteria (1 listed)
- subjects under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Thrombosis
Time frame: 15 months
To calculate the incidence of deep venous thrombosis from PICC lines in patients
1 secondary outcome
Demographic Risk Factor Association with Risk of Thrombosis from PICC or IJ access
Time frame: 15 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 24 Nov 2014.
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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.
Mary Hammes, MD principal investigator
University of Chicago
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 Thrombosis, run by University of Chicago at 1 site in United States.
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 24 Nov 2014. 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 United States. 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?
Incidence of Thrombosis (time frame: 15 months). 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 24 Nov 2014.