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Study Of Angiomax In Infants Under Six Months With Thrombosis

Primary Purpose

Thrombosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Angiomax (bivalirudin)
Sponsored by
The Medicines Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thrombosis focused on measuring neonates, thrombosis, bivalirudin, direct thrombin inhibitor

Eligibility Criteria

0 Years - 6 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Orange County

Outcomes

Primary Outcome Measures

Observation of improvement for thrombosis or by clinical exam such as: Decrease in size of thrombus, restoration of flow through an occluded vessel, decrease in diameter of extremity or head.

Secondary Outcome Measures

In addition, efficacy will also be judged by demonstrating a decrease in the molecular markers of thrombin generation.

Full Information

First Posted
August 7, 2002
Last Updated
January 31, 2006
Sponsor
The Medicines Company
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1. Study Identification

Unique Protocol Identification Number
NCT00043277
Brief Title
Study Of Angiomax In Infants Under Six Months With Thrombosis
Official Title
Pilot Dose Finding And Efficacy Study Of Angiomax® (Bivalirudin) As Primary Anticoagulation In Infants Under Six Months With Thrombosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The Medicines Company

4. Oversight

5. Study Description

Brief Summary
The goals of this study are: To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis; 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; 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: To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis; 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; 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis
Keywords
neonates, thrombosis, bivalirudin, direct thrombin inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Angiomax (bivalirudin)
Primary Outcome Measure Information:
Title
Observation of improvement for thrombosis or by clinical exam such as: Decrease in size of thrombus, restoration of flow through an occluded vessel, decrease in diameter of extremity or head.
Secondary Outcome Measure Information:
Title
In addition, efficacy will also be judged by demonstrating a decrease in the molecular markers of thrombin generation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy Young, MD
Organizational Affiliation
Children's Hospital Orange County
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States

12. IPD Sharing Statement

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Study Of Angiomax In Infants Under Six Months With Thrombosis

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