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 range

18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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