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

• Status: Completed
• Trial end date: 2019-12-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical College of Wisconsin
• Treatments: Calcium heparin; Heparin; Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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