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Home > "D" Clinical Trials Conditions > Dose Finding And Efficacy Study Of Angiomax In Infants Under Six Months With Thrombosis  Dose Finding And Efficacy Study Of Angiomax In Infants Under Six Months With Thrombosis
Dose Finding And Efficacy Study Of Angiomax In Infants Under Six Months With Thrombosis
For Condition: Thrombosis
Status: Recruiting
Sponsor(s): The Medicines Company ,
Synopsis: 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) 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).
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /6 Months
Genders: Both
Protocol Entry 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: - 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 (as defined in section 3.2, Secondary Endpoints)
Total Enrollment: 16
Location and Contact Information:
Children's Hospital of Orange County *Recruiting*
Orange, California, 92868
United States
Recruiting Guy Young 714-532-8459
Additional Information:
Study ID Numbers: TMC-BIV-02-04;
Study Start Date: August 2002
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043277
Other Thrombosis Studies:
1. Dose Finding And Efficacy Study Of Angiomax In Infants Under Six Months With Thrombosis
2. The inhibition of platelet antiaggregating activity of clopidogrel by atorvastatin detected by erythromycin breath test: a metabolic inhibition of hepatic cytochrome P450-3A
3. Heparin versus Lepirudin Flushes in Preventing Blockage of Venous Access Devices
4. Inflammation Markers Over Time in Cardiovascular Disease
5. Genetic Architecture of Plasma T-PA and PAI-1
Related Studies:
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Dose Finding And Efficacy Study Of Angiomax In Infants Under Six Months With Thrombosis
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