Study Of Angiomax In Infants Under Six Months With Thrombosis

NCT ID: NCT00043277

Last Updated: 2006-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-08-31
• Study Completion Date: 2004-12-31

Brief Summary

The goals of this study are:

1. To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis;

2. To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time (ACT) or activated partial thromboplastin time (aPTT) in Infants Under Six Months with arterial or venous thrombosis;

3. To determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin (UH) or low molecular weight heparin (LMWH).

Detailed Description

The goals of this study are:

1. To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis;

2. To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time (ACT) or activated partial thromboplastin time (aPTT) in Infants Under Six Months with arterial or venous thrombosis;

3. To determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin (UH) or low molecular weight heparin (LMWH).

Conditions

Thrombosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Angiomax (bivalirudin)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Parent/legal-guardian has provided written informed consent before initiation of any study related procedures.
• Objectively confirmed thrombotic event by either doppler ultrasound, echocardiogram, CT scan, MRI, MR angiogram, MR venogram, venogram or arteriogram.
• Age less than 6 months .
• Gestational age greater than 35 weeks
• Expected life expectancy at least 14 days.
• No contraindication to anticoagulation i.e. bleeding complications.

Exclusion Criteria

• Active or recent (less than 7 days) bleeding.
• Known allergy to Angiomax or hirudin, or known sensitivity to any component of the product.
• Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment.
• Refusal to undergo blood transfusion should it become necessary.
• Any other disease or condition, which, in the judgment of the Investigator would place a patient at undue risk by being enrolled in the trial.
• Baseline prolonged PT (>18 secs) or aPTT (>55 secs)
• Platelet count < 50,000 cells/mm3
• Birth Trauma
• Planned or indicated surgery within 30 days
• Major or minor bleeding event

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Medicines Company

INDUSTRY

Sponsor Role: lead

Principal Investigators

Guy Young, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Orange County

Locations

Children's Hospital of Orange County

Orange, California, United States

Countries

United States

Other Identifiers

TMC-BIV-02-04

Identifier Type: -

Identifier Source: org_study_id