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

NCT03672006 | Completed Phase 2 Results FDA Drug

• 1 other identifier: MCWisconsin
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Catheter-associated Venous Thrombosis

  Catheter-associated Venous Thrombosis upon ICU discharge or 30 days

  30 days or ICU discharge

• Catheter-associated Bloodstream Infection

  CLABSI

  30 days or ICU discharge

Secondary Outcomes (3)

• Episodes of CVC Dysfunction

  30 days or ICU discharge

• Off Study Use of t-PA

  30 days or ICU discharge

• Clinical Bleeding

  30 days or ICU discharge

Study Arms (2)

alteplase

EXPERIMENTAL

patients will receive 30 min-4 hours dwells of alteplase (recombinant t-PA) (2mg/2ml, up to 2mg per dose) to central venous catheter every 3 days (maximum 10 doses)

Biological: alteplase (recombinant t-PA)

Heparin

ACTIVE COMPARATOR

patients will receive 30 min-4 hours heparin (10U/ml, up to 2 ml per dose) dwells to central venous catheter every 3 days (maximum 10 doses)

Drug: Heparin

Interventions

alteplase (recombinant t-PA) BIOLOGICAL

Medication administered to dwell in central venous catheter

Also known as: tpa

alteplase

Heparin DRUG

Medication administered to dwell in central venous catheter

Also known as: control

Heparin

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53201, United States

Location

MeSH Terms

Conditions

Upper Extremity Deep Vein Thrombosis

Interventions

Tissue Plasminogen Activator; Tetradecanoylphorbol Acetate; Heparin

Condition Hierarchy (Ancestors)

Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors; Phorbol Esters; Phorbols; Diterpenes; Terpenes; Hydrocarbons; Organic Chemicals; Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Dr. Shelia Hanson
• Organization: Medical College of Wisconsin

shanson@mcw.edu

414-266-3728

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Centralized pharmacy will prepare and blind the study drug (t-PA) and the control (heparin)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 14, 2018
• Study Start: April 22, 2019
• Primary Completion: December 15, 2019
• Study Completion: December 15, 2019
• Last Updated: July 13, 2021
• Results First Posted: July 13, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)