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Pediatric High-Risk Deep Venous Thrombosis Lytic Outcomes Trial

NCT02767232 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2018-08-10

No results posted yet for this study

Summary

The purpose of this study is to determine if the use of adjunctive catheter-directed thrombolysis (CDT), which includes the intrathrombus administration of rt-PA (Activase/Alteplase), can prevent post-thrombotic syndrome (PTS) in pediatric patients with symptomatic proximal deep vein thrombosis (DVT) as compared with optimal standard anticoagulation alone.

Conditions

  • Deep Vein Thrombosis
  • Post-Thrombotic Syndrome
  • Venous Thrombosis

Interventions

DRUG

Recombinant tissue plasminogen activator (rt-PA)

Catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

DRUG

Standard Anticoagulation Therapy

Standard anticoagulation determined by physician for a period of 3-6 months

Sponsors & Collaborators

  • RTI International

    collaborator OTHER

  • Mid America Heart Institute

    collaborator OTHER

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Genentech, Inc.

    collaborator INDUSTRY

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Marilyn J Manco-Johnson, MD · University of Colorado Denver Anschutz Medical Campus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-31
Primary Completion
2023-04-30
Completion
2023-06-30
FDA Drug
Yes

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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 NCT02767232 on ClinicalTrials.gov