Non-Therapeutic Protocol
WARPG: Warfarin Pharmacogenetics In Pediatric Patients: Development And Testing Of a Pharmacogenetic–Based Dosing Algorithm
Type of Protocol/Clinical Study
Associated Hematology Studies
Description
This study focuses on learning information from the genetic material and data collection to help develop new guidelines and to improve the method for calculating the correct Coumadin dose for children.
Coumadin is a blood thinner that is taken by mouth. It prevents blood clots by blocking the action of certain clotting factors in the blood. Although Coumadin works very well, like many medications, side effects are possible. In the case of Coumadin, too much of the drug can cause bleeding problems while too little of the drug increases the risk for blood clots. Based on recent research in adult patients, it is known that certain inherited factors cause different people to break down the drug in the body differently; this results in the need for different doses of Coumadin for each individual person. It is also known that children require different doses than adults. The duration of the study will take place for 5 years.
Objectives
- To learn how the prescribed Coumadin dose for pediatric patients is affected by the child's age, sex, weight, height, and various inherited factors that break down Coumadin in the body.
- To use the information learned to develop a new guideline that the researchers hope will improve the method for calculating the correct Coumadin dose for children.
Eligibility
- Patient must be at least 6 months and less than or equal to 18 years of age at time of initiating Warfarin therapy.
- Patient must have been initiated on Warfarin therapy within the last 5 years.
- Patient will not be eligible for the study if there is lack of informed consent and/or assent as appropriate
- Female patients with a positive pregnancy test are not eligible
Principal Investigator
Ulrike Reiss, MD
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