Venous ThrombosisNCT00728819
Peripherally Inserted Central Catheter (PICC) Thrombosis: Reverse Taper Versus Non-tapered Catheters
A study testing Tapered PICC and Non-tapered PICC in people with Venous Thrombosis, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study is to compare two different marketed PICC (peripherally inserted central catheter) designs. Clotting rates, procedural bleeding and ease of catheter insertion will be compared. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Venous Thrombosis
- What is being tested?
- Tapered PICC and Non-tapered PICC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Aug 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All inpatients, age 18 to 90, in need of de novo central venous access with a double lumen catheter indication of > 2 weeks
- Informed consent and HIPAA consent forms discussed and signed by patient or their authorized representative
Who cannot join
- Skin related problems around the insertion site (infection, phlebitis, scars)
- History of mastectomy/axillary dissection on insertion side
- Coagulopathy with an INR of > 2.0
- Thrombocytopenia with platelets < 25,000 uL
- Renal insufficiency with a creatinine of > 3.0 mg/dL
- Documented current upper extremity or central venous thrombosis
Show all 10Show fewer
- Hypercoagulable states (protein C or S deficiency, AT-III deficiency, lupus anticoagulant)
- Catheters needed for therapy within less than an hour (emergent placement not allowing sufficient time for proper research consent and randomization)
- Patient has already been enrolled in this research study
- Life expectancy less than 1 month
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The purpose of this study is to compare two different marketed PICC (peripherally inserted central catheter) designs. Clotting rates, procedural bleeding and ease of catheter insertion will be compared. It is hypothesized that the non-tapered design has a lower clotting rate and is easier to place than the tapered design. Bleeding rates are expected to be about the same.
- Conditions
- Venous Thrombosis
- Being tested
- Tapered PICC, Non-tapered PICC
- Keywords
- Inpatients, Requiring, DL PICC, Access, Medications, Blood
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tapered PICCDevice
Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins
Non-tapered PICCDevice
Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Tapered PICC Receives: Device: Tapered PICC; Device: Non-tapered PICC |
| 2 | Active comparator | Non-tapered PICC Receives: Device: Non-tapered PICC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of PICC-related Venous Thrombosis
Number participants with vein thrombosis
Measured: 28 days, PICC removal or hospital discharge
Secondary outcomes (2)
Post-operative Bleeding
Post-operative bleeding
Measured: Day 1
Symptomatic PICC-related Venous Thrombosis
Symptomatic PICC-related venous thrombosis
Measured: Procedure through 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionJan 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxim Itkin, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728819
- Sponsor's protocol ID
- 807264
- Status last verified
- Mar 2018
- First submitted
- 31 Jul 2008
- Last updated
- 27 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Itkin M, Mondshein JI, Stavropoulos SW, Shlansky-Goldberg RD, Soulen MC, Trerotola SO. Peripherally inserted central catheter thrombosis--reverse tapered versus nontapered catheters: a randomized controlled study. J Vasc Interv Radiol. 2014 Jan;25(1):85-91.e1. doi: 10.1016/j.jvir.2013.10.009. Epub 2013 Nov 21.
PubMed 24268631
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripherally Inserted Central Catheter (PICC) Thrombosis: Reverse Taper Versus Non-tapered Catheters
- ClinicalTrials.gov ID
- NCT00728819
- Acronym / sponsor ID
- 807264
- Conditions
- Venous Thrombosis
- Keywords
- Inpatients, Requiring, DL PICC, Access, Medications, Blood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 6 Aug 2008 (estimated)
- Results
- Posted 27 Apr 2018
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 two different marketed PICC (peripherally inserted central catheter) designs. Clotting rates, procedural bleeding and ease of catheter insertion will be compared. It is hypothesized that the non-tapered design has a lower clotting rate and is easier to place than the tapered design. Bleeding rates are expected to be about the same.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Tapered PICC, Device: Non-tapered PICCTapered PICC |
| 2 | Active comparator | Device: Non-tapered PICCNon-tapered PICC |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All inpatients, age 18 to 90, in need of de novo central venous access with a double lumen catheter indication of > 2 weeks
- Informed consent and HIPAA consent forms discussed and signed by patient or their authorized representative
Key exclusion criteria (10 listed)
- Skin related problems around the insertion site (infection, phlebitis, scars)
- History of mastectomy/axillary dissection on insertion side
- Coagulopathy with an INR of > 2.0
- Thrombocytopenia with platelets < 25,000 uL
- Renal insufficiency with a creatinine of > 3.0 mg/dL
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 |
|---|---|---|
| Tapered PICCStandard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins | Device | 1 |
| Non-tapered PICCStandard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins | Device | 1, 2 |
Primary outcome
Evidence of PICC-related Venous Thrombosis
Time frame: 28 days, PICC removal or hospital discharge
Number participants with vein thrombosis
2 secondary outcomes
Post-operative Bleeding
Time frame: Day 1
Symptomatic PICC-related Venous Thrombosis
Time frame: Procedure through 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24268631Itkin M, Mondshein JI, Stavropoulos SW, Shlansky-Goldberg RD, Soulen MC, Trerotola SO. Peripherally inserted central catheter thrombosis--reverse tapered versus nontapered catheters: a randomized controlled study. J Vasc Interv Radiol. 2014 Jan;25(1):85-91.e1. doi: 10.1016/j.jvir.2013.10.009. Epub 2013 Nov 21.
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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.
Maxim Itkin, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tapered PICC and Non-tapered PICC in people with Venous Thrombosis, run by University of Pennsylvania 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 2 inclusion and 10 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 Apr 2018. 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?
Yes. Results are posted in the registry (first posted 27 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Evidence of PICC-related Venous Thrombosis (time frame: 28 days, PICC removal or hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00728819, which also lists 1 linked publication.
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 Apr 2018; AzTrials last refreshed its copy on 29 Oct 2026.