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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Tapered PICC |
|
| 2 | Active Comparator | Non-tapered PICC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tapered PICC | Device | Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of PICC-related Venous Thrombosis | Number participants with vein thrombosis | 28 days, PICC removal or hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Bleeding | Post-operative bleeding | Day 1 |
| Symptomatic PICC-related Venous Thrombosis | Symptomatic PICC-related venous thrombosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maxim Itkin, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24268631 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Non-tapered PICC | Non-tapered PICC Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Non-tapered PICC |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evidence of PICC-related Venous Thrombosis | Number participants with vein thrombosis | Posted | Count of Participants | Participants | 28 days, PICC removal or hospital discharge |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Purelence | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Professor of Radiology | Penn Medicine | 2156627892 | ITKINMAX@GMAIL.COM |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Non-tapered PICC | Device | Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins |
|
| Procedure through 28 days |
Non-tapered PICC Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Post-operative Bleeding | Post-operative bleeding | Number of participants who received the intervention as assigned | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Secondary | Symptomatic PICC-related Venous Thrombosis | Symptomatic PICC-related venous thrombosis | Number of participants who had this outcome measure | Posted | Count of Participants | Participants | Procedure through 28 days |
|
|
|
| 0 |
| 171 |
| 11 |
| 171 |
| EG001 | Non-tapered PICC | Non-tapered PICC Non-tapered PICC: Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins | 0 | 168 | 10 | 168 |
| fever | Infections and infestations | Systematic Assessment |
|
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