Efficacy of substitution therapy with PPSB concentrate in intensive care patients
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KeywordsVitamine Median Dose Prescribe Dosage Ethic Committee Approval Intensive Care Patient
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.
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.
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.
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.