Status:
COMPLETED
Pilot Dose Finding and Pharmacokinetic Study of Fondaparinux in Children With Thrombosis
Lead Sponsor:
Children's Hospital Los Angeles
Conditions:
Thrombosis
Heparin-induced Thrombocytopenia
Eligibility:
All Genders
1-18 years
Phase:
PHASE1
Brief Summary
This study will evaluate the use of a blood thinner, fondaparinux, which is approved for use in adults (not in children) in a children aged 1-18 years. Subject with a blood clot (thrombosis) or hepari...
Detailed Description
This clinical trial will assess the pharmacokinetics and safety of the novel anticoagulant, fondaparinux sodium (Arixtra) in pediatric patients with thromboembolism. Currently available anticoagulants...
Eligibility Criteria
Inclusion
- Children between 1 year and 18 years of age.
- The presence of documented venous or arterial thrombosis confirmed by diagnostic imaging.
- Weight greater than 8.3 kg.
- Signed informed consent/assent.
Exclusion
- Patients with active bleeding.
- Patients with planned invasive procedures less than 2 weeks from the time of enrollment.
- Patients with a contraindication to anticoagulation.
- Patients receiving thrombolytic agents.
- Patients with an INR\>1.5 or an activated partial thromboplastin time (PTT)\>40 seconds.
- Patients with a creatinine level above 1.2 times the upper limit of normal expected for age.
- Children \<1 year of age.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00412464
Start Date
September 1 2006
End Date
December 1 2009
Last Update
April 15 2015
Active Locations (4)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
2
Children's Hospital of Orange County
Orange, California, United States, 92868
3
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
4
Texas Children's Hospital
Houston, Texas, United States, 77030