DDAVP treatment combined with FVIII clotting factor concentrates in patients with mild haemophilia A. - DAVID

Erasmus University Medical Center0 个研究点开始时间: 2015年12月10日最近更新: 2016年5月30日

试验速览

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•-Mild hemophilia A patients (FVIII > 0.05 IU/mL)
•-In need of surgery
•-Age between 12 and 70 years at study inclusion date
•-Need for perioperative clotting factor concentrates
•-Treatment duration with FVIII-concentrates of at least 48 hours
•-Results of FVIII levels after a DDAVP test dose, or if test results are not admissible, willingness to undergo a DDAVP test
•-Male gender
•-(Parental) informed consent
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 6
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 4

•-Patients with other congenital or acquired hemostatic abnormalities
•-Very low response to DDAVP after 1 hour – absolute increase in FVIII < 0.2 IU/mL
•-Detectable FVIII inhibiting antibodies (>0.2 BU) in medical history or preoperatively, unless successfully treated with immunotolerance therapy
•-Contraindications for DDAVP, e.g. cardiovascular disease (see appendix IV)
•-Use of co-medication that has an interaction with DDAVP (see appendix IV)
•-Intolerance to previous DDAVP administrations
•-DDAVP not advisable due to the type of surgery according to the hematologist and/or surgeon

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