P. Massicotte et al., HOME MONITORING OF WARFARIN THERAPY IN CHILDREN WITH A WHOLE-BLOOD PROTHROMBIN TIME MONITOR, The Journal of pediatrics, 127(3), 1995, pp. 389-394
We prospectively evaluated a capillary whole blood prothrombin time (P
T) monitor (Biotrack, Ciba Coming) in an outpatient pediatric anticoag
ulation clinic (40 clinic patients) and in age-matched healthy subject
s (30 control subjects). Subsequently, 23 children requiring warfarin
therapy were placed on a home program (home patients) using the PT mon
itor; their parents were trained and the results followed by clinic st
aff, The PT results were reported as internationalized normalized rati
os (INRs). The laboratory and PT-monitor INR values were similar for t
he clinic patients and the control subjects (y = 0.76x + 0.38; r = 0.9
3; p < 0.001). The accuracy of the PT monitor (the difference between
INR values and the laboratory INR) was best at an INR of 2.5 to 3.5; 9
0% of paired INR values were within 0.8 INR units, The average duratio
n of monitoring for home patients was 13 months (range, 2 to 60 months
), They had an average of 3 dose measurements (range, I to 11 measurem
ents) and 1.8 dose changes (range, 0.6 to 4.5 changes) per month, Of t
he 599 measurements, 63% were within the therapeutic range, similar to
those for clinic patients; the dose requirements were also similar, T
here was 1 significant bleeding event, a subdural hematoma in a patien
t with an INR of 4.1, and 1 catheter-related thrombotic event with an
INR of 1.2; both children recovered, Of the 23 families, one discontin
ued home monitoring because of parental discomfort, 2 children died of
their primary disease, 6 completed warfarin therapy, and 14 remain on
the home program. We conclude that the whole blood PT/INR monitor is
safe and offers practical advantages to children requiring anticoagula
tion.