The Need for a Special Study
Kids-DOTT is a research study focused on determining the optimal blood thinner treatment for children that develop blood clots in their veins, a condition called "venous thrombosis." Although venous thrombosis has been recognized recently as an important health concern for children, most treatment information for blood clotting disorders is based on studies conducted on adults. However, diagnosing and treating children with venous thrombosis is very different from adult patients. This is because children’s bodies act very differently from adults’ bodies, even with similar clotting disorders. For this reason, it is very important to study venous thrombosis in children to specially cater blood thinning treatments to children.
Kids-DOTT is a collaborative study conducted at many specialized pediatric care centers across the U.S. by physician-investigators specializing in pediatric clotting disorders. The Kids-DOTT trial is the first multi-center trial to evaluate the duration of therapy for venous thrombosis in children. In the Kids-DOTT trial, children who have recently been diagnosed with acute venous thrombosis, and who are considered to be at relatively low risk for long-term complications, will be eligible to participate. Pre-screening for participants takes into consideration both features of the patient’s medical history and laboratory test results.
All patients participating in the study will be treated with standard blood thinner therapy for six weeks after a clot. After six weeks, patients will be randomly selected to either stop blood thinner therapy or continue for the remainder of the conventional treatment time, for a total of 3 months. All children will be followed at standard intervals for a total of 5 years in order to evaluate the long-term outcome of their thrombosis.
A "one size fits all" approach to treating venous thrombosis in children and adults does not seem to make sense, but due to limited medical research it has become the standard. Because most children are highly active, especially when compared to adults, and blood thinner treatment increases the risk for bleeding, children are often treated for 3 months. If the shortened treatment length is found to be just as effective as the conventional duration of blood thinner therapy, treatment would be more convenient and potentially safer for children with venous thrombosis who have similar features to those studied in the Kids-DOTT trial.