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

NCT03672006 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-07-13

Study results available
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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.

Conditions

  • Central Venous Catheter Thrombosis
  • Central Venous Catheter Associated Bloodstream Infection

Interventions

BIOLOGICAL

alteplase (recombinant t-PA)

Medication administered to dwell in central venous catheter

DRUG

Heparin

Medication administered to dwell in central venous catheter

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-22
Primary Completion
2019-12-15
Completion
2019-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03672006 on ClinicalTrials.gov