Introduction
Substitution of clotting factors is one of the most costly therapies in ICU treatment. However, efficacy of such treatment in clinical practice is poorly investigated. In a multi-centre trial we evaluated if substitution of PPSB-concentrate is able to raise clotting parameters.
Methods
In a multi-centre observational trial in 27 Austrian Hospitals and following ethics committee approval 280 patients (median age 58 [6–93]) were included in the study. During the observation period all patients requiring substitution with PPSB concentrate were included. No trigger-levels and no prescribed dosage was defined but patients received a PPSB-concentrate containing the vitamine K dependent factors II, VII, IX, X and the vitamin-dependent inhibitors C and S (Prothromplex® Total S-TIM 4, Baxter) as regarded clinically necessary by the physician concerned. Change in coagulation parameters, dosage applied, and adverse side-effects were registered. Statistical analysis based on the intention-to-treat principle while using the last value technique.
Results
Median dose applied was 21.4 IU/kg and lead to a median rise in Quick test from 38 to 62%. No side effects were reported. The increase was clinically sufficient in all cases and no further substitution was required.
Conclusion
For the first time in a representative number of patients we showed that the substitution of 1 IU/kg bodyweight PPSB concentrate raised Quick test by about 1%. Use of PPSB concentrate is save and no side effects, especially thrombosis were reported.