NL-OMON47474已完成不适用
DDAVP treatment combined with FVIII clotting factor concentrates in patients with mild hemophilia A. - DAVID
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 12 至 99（—）
入选标准
- •- Non-severe hemophilia A patients (FVIII equal to or higher than 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; perioperatively, or around a bleeding
- •- 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
排除标准
- •- Patients with other congenital or acquired hemostatic abnormalities
- •- Very low response to DDAVP after 1 hour * absolute increase in FVIII < 0.2
- •- Clinically relevant FVIII inhibiting antibodies (>0.5 BU) in medical history
- •or preoperatively, unless successfully treated with immunotolerance therapy
- •- Start of FVIII-concentrate treatment >24 hours ago
- •- Contraindications for DDAVP, e.g. cardiovascular disease (see the protocol,
- •appendix IV)
- •- Use of co-medication that has an interaction with DDAVP (see the protocol,
- •appendix IV)
- •- Intolerance to previous DDAVP administrations
- •- DDAVP not advisable due to the type of surgery/bleeding according to the
- •hematologist and/or surgeon
研究者
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