DDAVP treatment combined with FVIII clotting factor concentrates in patients with mild hemophilia A

Erasmus Medical Center Rotterdam0 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•Non-severe hemophilia A patients (FVIII = 0.01 IU/mL)
•-In need of surgery or suffering from bleeding
•-Age minimally 12 and maximally 70 years at study inclusion date
•-Need for 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 available, willingness to undergo a DDAVP test
•-Male gender
•-(Parental) informed consent

•-Patients with other congenital or acquired hemostatic abnormalities
•-Very low response to DDAVP after 1 hour – absolute increase in FVIII < 0.2 IU/mL
•-Clinically relevant FVIII inhibiting antibodies (>0.5 BU) 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 type of surgery or bleeding according to the hematologist and/or surgeon
•-Start of FVIII-concentrate treatments >24 hours ago

发起方

Erasmus Medical Center Rotterdam