The UNBLOCK Study: Utilization of Bivalirudin On Clots in Kids

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Thrombosis is a significant medical complication in children with chronic diseases. The currently utilized treatments have many drawbacks which can lead to poor outcomes. More modern therapies are available but have not been systematically tested in children. This study will determine whether one such medication, bivalirudin is a safer and more effective alterative.

This study will monitor what effects the drug has upon the child's body and how the body processes the study drug (absorption, metabolism and elimination). The study will also evaluate the drug's effectiveness by following how long it takes to dissolve the clot. The safety issues being monitored relate to any observations of major or minor bleeding episodes after taking the drug, and/or any other side effects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Los Angeles
• Collaborators: Baylor College of Medicine; Children's Hospital Colorado; Children's Hospital of Philadelphia; Nationwide Children's Hospital; Texas Children's Hospital; University of Texas Southwestern Medical Center
• Treatments: Bivalirudin; Hirudins

Criteria

Inclusion Criteria:

• Children > 6 months to < 18 years of age.

• Deep vein thrombosis demonstrated by objective testing (Duplex ultrasonography, venography, CT venography, MR venography, echocardiography). This imaging must be performed within 72 hours prior to initiation of study drug if no other anticoagulation has been started. If receiving other anticoagulation prior to start of study drug, imaging must be performed within 24 hours of study drug initiation.

• Informed consent and assent from parent/guardian/patient

Exclusion Criteria:

• Treatment of present thrombus with thrombolytic agent.

• Treatment of present thrombus with another anticoagulant for more than 48 hours (low dose heparin for maintenance of venous or arterial catheter patency is allowed).

• Baseline prothrombin time (PT) which is more than 3 seconds above the upper limit of normal or baseline activated partial thromboplastin time (aPTT) which is more than 5 seconds above the upper limit of normal.

• Creatinine which is more than 20% above the upper limit of normal for age.

• Presence of a known bleeding disorder.

• Active bleeding.

• Planned invasive procedure within 3 days.

• Known pregnancy