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The purpose of this study is to determine the rate and timing of interventions and complications related to the use of peripherally inserted central venous catheters in adult patients.
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of PICC Line Occlusions | The incidence, severity and management of PICC line occlusions were recorded for each of the enrolled subjects. | Insertion to Removal / maximum 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients necessitating insertion of a PICC for fluid, nutritional, chemotherapy or antibiotic treatment for a minimum of 14 days.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm Study | Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Study | Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Rate of PICC Line Occlusions | The incidence, severity and management of PICC line occlusions were recorded for each of the enrolled subjects. | Posted | Number | percentage of enrolled subjects | Insertion to Removal / maximum 3 months |
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This observationaol study included recording of line occlusions and incidence of venous thrombosis from the time of PICC insertion until removal of the PICC line or for a maximum of 90 days.
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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 | Single Arm Study | Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Venous thrombosis | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment | Symptomatic venous thrombus in upper extremity ( PICC arm); verified via standard ultrasonography procedure. |
Further comparative studies standarizing the management of PICC line flushing solutions and type if PICC line required to provide comparative and evidence based clinical practice recommendations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ulla Wallin, Director of Clinical Research | Semprus BioSciences | 1-617-577-2205 | ulla.wallin@semprusbio.com |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 101 |
| 6 |
| 101 |
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