Pediatric Venous Thromboembolism Clinical Trial
Official title:
Analysis of Laboratory Markers to Predict Risk of Catheter Related Thrombosis
| NCT number | NCT04117217 |
| Other study ID # | 1701146088R002 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 1, 2017 |
| Est. completion date | December 2026 |
| Verified date | October 2019 |
| Source | University of Arizona |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This project addresses the role of lab markers around the time of central line placement in predicting risk of thrombosis in pediatric patients with central venous lines being placed. The project proposes an innovative way to predict higher risk of thrombosis in the pediatric population to give clinicians a valid tool to guide clinical practice for these patients.
| Status | Recruiting |
| Enrollment | 350 |
| Est. completion date | December 2026 |
| Est. primary completion date | December 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Months to 17 Years |
| Eligibility |
Inclusion Criteria: - Patients over 5 kg and less than 18 years of age. - Patients having a central venous catheter or cardiac catheterization performed Exclusion Criteria: - prior history of thrombosis - patients with hemophilia A or B |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Arizona | Tucson | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| University of Arizona |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Thrombosis | Patients will be enrolled during the time of central line placements and labs would be drawn during line placement. Patients will be followed prospectively for a catheter related t thrombosis event or not. Lab markers and clinical states of patients who develop or do not develop a thrombosis will be analyzed | within one year of enrollment |