Study Of Angiomax In Infants Under Six Months With Thrombosis
Thrombosis
About this trial
This is an interventional treatment trial for Thrombosis focused on measuring neonates, thrombosis, bivalirudin, direct thrombin inhibitor
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
Sites / Locations
- Children's Hospital of Orange County