Venous Thrombosis
Conditions
Keywords
Inpatients, Requiring, DL PICC, Access, Medications, Blood
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.
Interventions
DEVICETapered PICC
Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins
DEVICENon-tapered PICC
Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evidence of PICC-related Venous Thrombosis | 28 days, PICC removal or hospital discharge | Number participants with vein thrombosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Bleeding | Day 1 | Post-operative bleeding |
| Symptomatic PICC-related Venous Thrombosis | Procedure through 28 days | Symptomatic PICC-related venous thrombosis |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Taper PICC Tapered PICC
Tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins
Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins | 171 |
| Non-tapered PICC Non-tapered PICC
Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins | 168 |
| Total | 339 |
Baseline characteristics
| Characteristic | Taper PICC | Non-tapered PICC | Total |
|---|---|---|---|
| Age, Customized 18-90 yo | 171 Participants | 168 Participants | 339 Participants |
| Region of Enrollment United States | 171 Participants | 168 Participants | 339 Participants |
| Sex: Female, Male Female | 77 Participants | 71 Participants | 148 Participants |
| Sex: Female, Male Male | 94 Participants | 97 Participants | 191 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 171 | 10 / 168 |
| serious Total, serious adverse events | 0 / 171 | 0 / 168 |
Outcome results
Primary
Evidence of PICC-related Venous Thrombosis
Number participants with vein thrombosis
Time frame: 28 days, PICC removal or hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Taper PICC | Evidence of PICC-related Venous Thrombosis | 102 Participants |
| Non-tapered PICC | Evidence of PICC-related Venous Thrombosis | 95 Participants |
Secondary
Post-operative Bleeding
Post-operative bleeding
Time frame: Day 1
Population: Number of participants who received the intervention as assigned
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Taper PICC | Post-operative Bleeding | 4 Participants |
| Non-tapered PICC | Post-operative Bleeding | 9 Participants |
Secondary
Symptomatic PICC-related Venous Thrombosis
Symptomatic PICC-related venous thrombosis
Time frame: Procedure through 28 days
Population: Number of participants who had this outcome measure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Taper PICC | Symptomatic PICC-related Venous Thrombosis | 6 Participants |
| Non-tapered PICC | Symptomatic PICC-related Venous Thrombosis | 7 Participants |