Performance characteristics and clinical evaluation of an in vitro bleeding time device--Thrombostat 4000.

The performance characteristics of an in vitro bleeding time device--Thrombostat 4000 were evaluated and compared with the Simplate bleeding time in healthy individuals and patients with disorders of primary hemostasis. Reference ranges were established using 30 normal volunteers. Although there were variations between different filter batches, reproducibility was good within a single batch. There were no differences between the two channels of the instrument and between male and female subjects. Hematocrit correlated negatively with the initial flow (IF) and IF correlated positively with closure time (T) and bleeding volume (V). Aspirin could be detected only when the traditional addition of ADP was replaced with CaCl2. Both, closure time (T) or bleeding volume (V) were more sensitive than Simplate bleeding time and T was more sensitive than V in detecting patients with disorders of primary hemostasis. We conclude that the Thrombostat 4000 is a reproducible, reliable, sensitive and easy to use instrument. It is superior to the traditional in vivo bleeding times for investigations of disorders of primary hemostasis (screening, diagnosis, monitoring, etc.).