Why the study?
Does self-management of oral anticoagulation therapy improve time in therapeutic range in children with congenital heart disease?
Does self-management of oral anticoagulation therapy improve time in therapeutic range in children with congenital heart disease?
Self-management of oral anticoagulation therapy in children with congenital heart disease is safe and achieves a high proportion of time in the therapeutic INR range.
May support self-management feasibility in pediatric CHD; leaves open randomized confirmation of TTR improvement versus standard care.
BACKGROUND: Children with congenital heart disease and who are on oral anticoagulation therapy present special challenges due to, for example, rapid fluctuations in international normalized ratio (INR) values, interruption in daily life due to frequent hospital/doctor visits, and difficulties and pain to the child in the performance of venipuncture. We hypothesize that oral anticoagulation therapy can be successfully controlled by self-management for this subset of patients. The aim of this study was to assess the treatment quality of self-managed oral anticoagulation therapy as the proportion of time within the therapeutic INR target range in children with congenital heart disease. METHODS: Children (N = 22) with a mean age of 10.6 years (range, 1.8-18.6 years) and their parents were trained in home blood analysis of INR and in coumarin dosage adjustment. After training, the children were monitored by weekly INR measurements. The therapeutic range in target INR values was +/-0.5. The indications for initiating oral anticoagulation therapy were the presence of a mechanical heart valve (n = 16) and total cavopulmonary connection (n = 6). The children had no physical restrictions. RESULTS: The mean observation time was 3.6 years (range, 0.9-5.8 years), and the total number of patient-years was 75.4. The patients were within the therapeutic INR target range for a median of 73.1% (range, 30.3%-91.0%) of the observation time. Two children died for reasons not related to the oral anticoagulation therapy. None of the patients experienced thromboembolic or bleeding complications requiring doctor intervention. CONCLUSION: Self-management of oral anticoagulation therapy is safe and provides a good quality of treatment for selected children with congenital heart disease.
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Christensen et al. (2004) studied this question.
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