CompletedPhase 2

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

United States20 participantsStarted 2019-04-22

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Catheter-associated Venous Thrombosis

Timeframe: 30 days or ICU discharge

Catheter-associated Bloodstream Infection

Timeframe: 30 days or ICU discharge

Trial details

NCT IDNCT03672006

SponsorMedical College of Wisconsin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-15

Results submitted2021-06-21

View on ClinicalTrials.gov More Central Venous Catheter Thrombosis trials