2021
DOI: 10.1016/s2352-3026(21)00135-6
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Perioperative pharmacokinetic-guided factor VIII concentrate dosing in haemophilia (OPTI-CLOT trial): an open-label, multicentre, randomised, controlled trial

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Cited by 12 publications
(26 citation statements)
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“…35 However, a recent randomized controlled perioperative trial was not able to show a decrease in FVIII concentrate consumption, although achievement of FVIII target ranges was clearly more optimal. 36 We hypothesize PK-guided dosing leads to individualization of prophylaxis which is in accordance with the recommendations of the subcommittee on FVIII, FIX, and rare bleeding disorders of the International Society on Thrombosis and Haemostasis (ISTH). 37 PK-guided dosing may help achieve higher trough levels more efficiently when clinically indicated, as well as provide guidance when patients switch to alternative replacement factor concentrates, while taking cost and benefit of treatment into account.…”
Section: Pharmacokinetic-guided Dosingmentioning
confidence: 77%
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“…35 However, a recent randomized controlled perioperative trial was not able to show a decrease in FVIII concentrate consumption, although achievement of FVIII target ranges was clearly more optimal. 36 We hypothesize PK-guided dosing leads to individualization of prophylaxis which is in accordance with the recommendations of the subcommittee on FVIII, FIX, and rare bleeding disorders of the International Society on Thrombosis and Haemostasis (ISTH). 37 PK-guided dosing may help achieve higher trough levels more efficiently when clinically indicated, as well as provide guidance when patients switch to alternative replacement factor concentrates, while taking cost and benefit of treatment into account.…”
Section: Pharmacokinetic-guided Dosingmentioning
confidence: 77%
“… 35 However, a recent randomized controlled perioperative trial was not able to show a decrease in FVIII concentrate consumption, although achievement of FVIII target ranges was clearly more optimal. 36 …”
Section: Introductionmentioning
confidence: 99%
“…Detailed information on this trial can be found in the trial design paper 11 and recent publication. 12 In brief, this perioperative trial included patients with severe or moderate haemophilia A from Haemophilia Treatment Centres in the Netherlands to compare PK-guided iterative perioperative FVIII concentrate dosing with standard treatment. Following a bolus of 50 IU/kg FVIII concentrate, the preoperative PK profiles were constructed using three blood samples.…”
Section: Methodsmentioning
confidence: 99%
“…We analyzed patient data from the individual preoperative PK profiles from the OPTI‐CLOT randomized controlled trial. Detailed information on this trial can be found in the trial design paper 11 and recent publication 12 . In brief, this perioperative trial included patients with severe or moderate haemophilia A from Haemophilia Treatment Centres in the Netherlands to compare PK‐guided iterative perioperative FVIII concentrate dosing with standard treatment.…”
Section: Methodsmentioning
confidence: 99%
“…Both models will be fit on a retrospective data set, 5 and will be validated on data collected during the OPTI‐CLOT randomized controlled trial. 6 …”
Section: Introductionmentioning
confidence: 99%