Venous ThrombosisPhase 3PICNICNCT01495429
Peripherally Inserted Versus Centrally Inserted Central Venous Catheters in the Neurological Intensive Care
A Phase 3 study testing Central venous catheter in people with Venous Thrombosis, run by University of Michigan at 2 sites in United States.
Trial summary
The investigators aim to compare the complications between centrally and peripherally inserted central venous catheters in neurological intensive care unit patients. The study hypothesis is that peripherally inserted catheters will have more cumulative complications due to venous thrombosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thrombosis
- What is being tested?
- Central venous catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2012to Jul 2015
- Phase
- Phase 3
- 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
Who may be able to join
- all patients age > 18, admitted to the neurological ICU who are require a de novo central venous catheter as standard of care and in which a double lumen 5f PICC or CICVC (triple lumen, 7f) are acceptable for the indication.
- the patients must be expected to survive and need a central venous catheter for at least 7 days.
Who cannot join
- prisoner
- age < 18
- expected to die or have care withdrawn prior to ICU day 7
- requiring an emergent central venous catheter
- suspected bacteremia
- recent central venous catheter within the last 30 days
Show all 10Show fewer
- patients who are not a candidate for bedside placement of either a CICVC or PICC line
- patients with renal insufficiency with creatinine level greater than 3.0 mg/dL (265.2 m mol/L) or who were undergoing hemodialysis
- patients requiring a central venous catheter for prolonged antibiotic therapy\
- patient who the treating clinician feels clearly needs one particular type of catheter over the other
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan Health System
Ann Arbor, Michigan, 48103
Bronson Methodist Hospital
Kalamazoo, Michigan, 49001
About this study
Official title: A Phase III Study of Peripherally Inserted Versus Centrally Inserted Central Venous Catheters in the Neurological Intensive Care Unit
The investigators aim to compare the complications between centrally and peripherally inserted central venous catheters in neurological intensive care unit patients. The study hypothesis is that peripherally inserted catheters will have more cumulative complications due to venous thrombosis.
- Conditions
- Venous Thrombosis
- Being tested
- Central venous catheter
- Keywords
- catheter related large vein thrombosis, upper extremity deep venous thrombosis, central venous catheters, upper extremity catheter related large vein thrombosis
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central venous catheterProcedure or surgery
Placement of a peripherally inserted central venous catheter
Central venous catheterProcedure or surgery
Placement of a centrally inserted central venous catheter
| Study group | Role | What they receive |
|---|---|---|
| PICC line (Peripherally) | Experimental | placement of a picc line Receives: Procedure: Central venous catheter |
| CICVC (central insertion) | Active comparator | placement of a centrally inserted central venous catheter Receives: Procedure: Central venous catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite of death or catheter related large vein thrombosis
Measured: 15 days
Secondary outcomes (1)
Cumulative catheter related complications until discharge
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionJul 2015
- Study completionJul 2015
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 University of MichiganThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey J Fletcher, University of Michigan
- Investigators
- Jeffrey J Fletcher, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01495429
- Sponsor's protocol ID
- HUM00050032
- Acronym
- PICNIC
- Status last verified
- Aug 2015
- First submitted
- 13 Dec 2011
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study of Peripherally Inserted Versus Centrally Inserted Central Venous Catheters in the Neurological Intensive Care Unit
- ClinicalTrials.gov ID
- NCT01495429
- Acronym / sponsor ID
- PICNIC / HUM00050032
- Conditions
- Venous Thrombosis
- Keywords
- catheter related large vein thrombosis, upper extremity deep venous thrombosis, central venous catheters, upper extremity catheter related large vein thrombosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 20 Dec 2011 (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 investigators aim to compare the complications between centrally and peripherally inserted central venous catheters in neurological intensive care unit patients. The study hypothesis is that peripherally inserted catheters will have more cumulative complications due to venous thrombosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PICC line (Peripherally) | Experimental | Procedure: Central venous catheterplacement of a picc line |
| CICVC (central insertion) | Active comparator | Procedure: Central venous catheterplacement of a centrally inserted central venous catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- all patients age > 18, admitted to the neurological ICU who are require a de novo central venous catheter as standard of care and in which a double lumen 5f PICC or CICVC (triple lumen, 7f) are acceptable for the indication.
- the patients must be expected to survive and need a central venous catheter for at least 7 days.
Key exclusion criteria (10 listed)
- prisoner
- age < 18
- expected to die or have care withdrawn prior to ICU day 7
- requiring an emergent central venous catheter
- suspected bacteremia
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 |
|---|---|---|
| Central venous catheterPlacement of a peripherally inserted central venous catheter | Procedure or surgery | PICC line (Peripherally) |
| Central venous catheterPlacement of a centrally inserted central venous catheter | Procedure or surgery | CICVC (central insertion) |
Primary outcome
The composite of death or catheter related large vein thrombosis
Time frame: 15 days
1 secondary outcome
Cumulative catheter related complications until discharge
Time frame: 30 days
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 4 Aug 2015.
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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.
Jeffrey J Fletcher, MD principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Central venous catheter in people with Venous Thrombosis, run by University of Michigan at 2 sites 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 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The composite of death or catheter related large vein thrombosis (time frame: 15 days). 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 4 Aug 2015.