Peripherally Inserted Central Catheter (PICC) Thrombosis: Reverse Taper Versus Non-tapered Catheters

Study Overview
=================
Brief 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.

Official Title
-----------------
Peripherally Inserted Central Catheter (PICC) Thrombosis: Reverse Taper Versus Non-tapered Catheters

Conditions
-----------------
Venous Thrombosis

Intervention / Treatment
-----------------
* Device: Tapered PICC
* Device: Non-tapered PICC


Participation Criteria
=================
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 < 25,000 uL Renal insufficiency with a creatinine of > 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Tapered PICC | Device: Tapered PICC<br>* Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins<br>Device: Non-tapered PICC<br>* Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins<br>|
| Active Comparator: 2<br>Non-tapered PICC | Device: Non-tapered PICC<br>* Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of PICC-related Venous Thrombosis | Number participants with vein thrombosis | 28 days, PICC removal or hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Bleeding | Post-operative bleeding | Day 1 | 
| Symptomatic PICC-related Venous Thrombosis | Symptomatic PICC-related venous thrombosis | Procedure through 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inpatients, Requiring, DL PICC, Access, Medications, Blood