Study Of Angiomax In Infants Under Six Months With Thrombosis
Completed · Phase 2
Conditions studied: Thrombosis
In brief
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).
Key facts
- Study ID
- NCT00043277
- Run by
- The Medicines Company
- People needed
- 25
- Starts
- 2002-08-01
- Expected to finish
- 2004-12-01
- Last updated by the study team
- 2006-02-01
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Children's Hospital of Orange County — Orange, California, United States
Full record on ClinicalTrials.gov
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