N/A
N=339
Peripherally Inserted Central Catheter (PICC) Thrombosis: Reverse Taper Versus Non-tapered Catheters
Venous Thrombosis
Bottom Line
View on ClinicalTrials.gov: NCT00728819 ↗Enrolled (actual)
339
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Evidence of PICC-related Venous Thrombosis — 102; 95 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tapered PICC (Device); Non-tapered PICC (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evidence of PICC-related Venous Thrombosis |
102; 95 | — |
| SECONDARY Post-operative Bleeding |
4; 9 | — |
| SECONDARY Symptomatic PICC-related Venous Thrombosis |
6; 7 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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 3.0 mg/dL
- Documented current upper extremity or central venous thrombosis
- 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
Data sourced from ClinicalTrials.gov (NCT00728819). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.