TY - JOUR
T1 - Vaste versus variabele dosering protrombinecomplex bij couperen van cumarinetherapie (PROPER-studie)
AU - Khorsand, N.
AU - Veeger, N. J. G. M.
AU - Heidt, J.
AU - Overdiek, J. W. P. M.
AU - van Hest, R. M.
AU - Meijer, K.
PY - 2011/2/18
Y1 - 2011/2/18
N2 - OBJECTIVE: To investigate the clinical outcome of two dosing strategies of prothrombin complex concentrate (PCC). Although PCC is often used to counteract vitamin K antagonist (VKA) therapy, evidence regarding the optimal dose for this indication is lacking. In Dutch hospitals, either a variable dose based on body weight, initial and target INR or a fixed dose strategy is used. DESIGN: The presented PROPER-study is a prospective, observational, non-inferiority cohort study. METHODS: Consecutive patients receiving PCC for VKA reversal because of a major non-cranial bleeding were enrolled in two cohorts. In cohort 1, patients were treated according to the fixed dose strategy and in cohort 2 according to the variable dose strategy. Study endpoints were proportion of patients reaching the target INR <2, successful clinical outcome, actually reached INR, and actual dose of PCC used. RESULTS: At the time of this interim analysis, 64 and 103 patients were included in cohort 1 and 2, respectively. Target INR was reached in 92% of patients in cohort 1 versus 97% in cohort 2. Successful clinical outcome was seen in 94% in cohort 1 versus 86% in cohort 2. Median INR decreased from 6.0 to 1.5 in cohort 1 with a median dose of 40 ml PCC versus 5.9 to 1.4 with a median dose of 60 ml PCC in cohort 2. CONCLUSION: The PROPER study shows that target INR is reached in fewer patients in the fixed dose cohort compared to the variable dose cohort. This does not result in less successful clinical outcome.
AB - OBJECTIVE: To investigate the clinical outcome of two dosing strategies of prothrombin complex concentrate (PCC). Although PCC is often used to counteract vitamin K antagonist (VKA) therapy, evidence regarding the optimal dose for this indication is lacking. In Dutch hospitals, either a variable dose based on body weight, initial and target INR or a fixed dose strategy is used. DESIGN: The presented PROPER-study is a prospective, observational, non-inferiority cohort study. METHODS: Consecutive patients receiving PCC for VKA reversal because of a major non-cranial bleeding were enrolled in two cohorts. In cohort 1, patients were treated according to the fixed dose strategy and in cohort 2 according to the variable dose strategy. Study endpoints were proportion of patients reaching the target INR <2, successful clinical outcome, actually reached INR, and actual dose of PCC used. RESULTS: At the time of this interim analysis, 64 and 103 patients were included in cohort 1 and 2, respectively. Target INR was reached in 92% of patients in cohort 1 versus 97% in cohort 2. Successful clinical outcome was seen in 94% in cohort 1 versus 86% in cohort 2. Median INR decreased from 6.0 to 1.5 in cohort 1 with a median dose of 40 ml PCC versus 5.9 to 1.4 with a median dose of 60 ml PCC in cohort 2. CONCLUSION: The PROPER study shows that target INR is reached in fewer patients in the fixed dose cohort compared to the variable dose cohort. This does not result in less successful clinical outcome.
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=79952204240&origin=inward
M3 - Article
SN - 0031-6911
VL - 146
SP - 33
EP - 36
JO - Pharmaceutisch Weekblad
JF - Pharmaceutisch Weekblad
IS - 7
ER -