t-PA Prophylaxis to Prevent Catheter-associated Thrombosis and Infection

Completed · Phase 2

Conditions studied: Central Venous Catheter Thrombosis, Central Venous Catheter Associated Bloodstream Infection

In brief

The purpose of this pilot study is to test feasibility of concept, consent and enrollment rates, and mechanics of study designed to assess if intra-catheter dwells of tissue plasminogen activator (t-PA) is effective in decreasing the rate of clinically diagnosed central line associated blood stream infection (CLABSI) or venous thromboembolism (VTE) in central venous catheters (CVC) compared to standard of care heparin dwell.

Key facts

Study ID

NCT03672006

Run by

Medical College of Wisconsin

People needed

20

Starts

2019-04-22

Expected to finish

2019-12-15

Last updated by the study team

2021-07-13

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 0 - ≤ 18 years old
• PICU admission
• CVC placed within 72 hours of enrollment (tunneled such as peripherally inserted central catheter (PICC), Broviac or Hickman, or untunneled) and in place during hospitalization

You may not qualify if…

• Pregnancy
• Non-English-speaking subjects and/or parent/guardian
• Platelet count < 20,000
• Active CVC infection-defined as positive blood culture from the in -situ CVC at time of enrollment
• Current radiographically confirmed VTE
• Currently receiving treatment doses of anticoagulation (heparin infusion >15U/kg/hr, enoxaparin injections >=2mg/kg/day or >=60mg/day)
• CVC diameter <1.9 Fr
• Current or previous diagnosis of Heparin Induced Thrombocytopenia or allergy to heparin or t-PA
• Med-a-port catheters

Where it is running

• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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