Phase 2
N=20
t-PA Prophylaxis to Prevent Catheter-associated Thrombosis and Infection
Central Venous Catheter Thrombosis · Central Venous Catheter Associated Bloodstream Infection
Bottom Line
View on ClinicalTrials.gov: NCT03672006 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Catheter-associated Venous Thrombosis — 3; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- alteplase (recombinant t-PA) (Biological); Heparin (Drug)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Medical College of Wisconsin
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Catheter-associated Venous Thrombosis |
3; 3 | — |
| PRIMARY Catheter-associated Bloodstream Infection |
0; 0 | — |
| SECONDARY Episodes of CVC Dysfunction |
5; 2 | — |
| SECONDARY Off Study Use of t-PA |
0.5; 0 | — |
| SECONDARY Clinical Bleeding |
0; 0 | — |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT03672006). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.