PMID- 21073580 OWN - NLM STAT- MEDLINE DCOM- 20110620 LR - 20141113 IS - 1365-3148 (Electronic) IS - 0958-7578 (Linking) VI - 21 IP - 2 DP - 2011 Apr TI - Fixed versus variable dose of prothrombin complex concentrate for counteracting vitamin K antagonist therapy. PG - 116-23 LID - 10.1111/j.1365-3148.2010.01050.x [doi] AB - BACKGROUND: Although prothrombin complex concentrate (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, target INR (international normalised ratio) and initial INR, or a fixed dose is used. AIM/OBJECTIVES: In this observational, pilot study, the efficacy and feasibility of the fixed dose strategy compared to the variable dosing regimen, is investigated. MATERIALS AND METHODS: Consecutive patients receiving PCC (Cofact(R), Sanquin, Amsterdam) for VKA reversal because of a major non-cranial bleed or an invasive procedure were enrolled in two cohorts. Data were collected prospectively in the fixed dose group, cohort 1, and retrospectively in the variable dose regimen, cohort 2. Study endpoints were proportion of patients reaching target INR and successful clinical outcome. RESULTS: Cohort 1 consisted of 35 and cohort 2 of 32 patients. Target INR was reached in 70% of patients in cohort 1 versus 81% in cohort 2 (P = 0.37). Successful clinical outcome was seen in 91% of patients in cohort 1 versus 94% in cohort 2 (P = 1.00). Median INR decreased from 4.7 to 1.8 with a median dosage of 1040 IU factor IX (F IX) in cohort 1 and from 4.7 to 1.6 with a median dosage of 1580 IU F IX in cohort 2. CONCLUSION: This study suggests that a fixed dose of 1040 IU of F IX may be an effective way to rapidly counteract VKA therapy in our patient population and provides a basis for future research. CI - (c) 2010 The Authors. Transfusion Medicine (c) 2010 British Blood Transfusion Society. FAU - Khorsand, N AU - Khorsand N AD - Department of Hospital Pharmacy, Medical Centre Haaglanden, The Hague, The Netherlands. N.Khorsand@hagaziekenhuis.nl FAU - Veeger, N J G M AU - Veeger NJ FAU - Muller, M AU - Muller M FAU - Overdiek, J W P M AU - Overdiek JW FAU - Huisman, W AU - Huisman W FAU - van Hest, R M AU - van Hest RM FAU - Meijer, K AU - Meijer K LA - eng PT - Journal Article DEP - 20101115 PL - England TA - Transfus Med JT - Transfusion medicine (Oxford, England) JID - 9301182 RN - 0 (Anticoagulants) RN - 0 (Antidotes) RN - 0 (Blood Coagulation Factors) RN - 12001-79-5 (Vitamin K) RN - 37224-63-8 (prothrombin complex concentrates) RN - 5Q7ZVV76EI (Warfarin) RN - I6WP63U32H (Acenocoumarol) RN - Q08SIO485D (Phenprocoumon) SB - IM MH - Acenocoumarol/adverse effects/antagonists & inhibitors MH - Adult MH - Aged MH - Aged, 80 and over MH - Anticoagulants/adverse effects/*antagonists & inhibitors MH - Antidotes/*administration & dosage/therapeutic use MH - Blood Coagulation Factors/*administration & dosage/therapeutic use MH - Cohort Studies MH - Dose-Response Relationship, Drug MH - Female MH - Hemorrhage/chemically induced/prevention & control MH - Humans MH - International Normalized Ratio MH - Male MH - Middle Aged MH - Phenprocoumon/adverse effects/antagonists & inhibitors MH - Prospective Studies MH - Retrospective Studies MH - Vitamin K/*antagonists & inhibitors MH - Warfarin/adverse effects/antagonists & inhibitors EDAT- 2010/11/16 06:00 MHDA- 2011/06/21 06:00 CRDT- 2010/11/16 06:00 PHST- 2010/11/16 06:00 [entrez] PHST- 2010/11/16 06:00 [pubmed] PHST- 2011/06/21 06:00 [medline] AID - 10.1111/j.1365-3148.2010.01050.x [doi] PST - ppublish SO - Transfus Med. 2011 Apr;21(2):116-23. doi: 10.1111/j.1365-3148.2010.01050.x. Epub 2010 Nov 15.