ISRCTN04929580已完成不适用
In vivo changes in haemostasis after intravenous administration of plasma-derived factor VII and recombinant factor VII(a): a randomised controlled cross over multicentre intervention study
Radboud University Nijmegen Medical Center (Netherlands)0 个研究点目标入组 10 人开始时间: 2011年7月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Factor VII clotting activity of less than 5%
- •2. Age 18 years or older
- •3. Wash-out period of pdFVII or rFVII(a) of at least 3 days
- •4. Male or female
- •5. The intention to participate in a cross-over design (treated-twice)
排除标准
- •1. Age < 18 years
- •2. Known allergy to plasma proteins
- •3. Bleeding episode resulting in a drop in haemoglobin (Hb) levels of >1 mmol/l (64.5 g/l), trauma or surgery in the last 6 weeks
- •4. Fever (> 38 degrees centigrade)
- •5. Clinical indication of liver cirrhosis (echographic indication, enlarged spleen, enlarged liver, decreased platelet count)
- •6. Hepatitis C recently treated with interferon (wash-out 6 months)
- •7. Human immunodeficiency virus (HIV) positive
- •8. Pregnancy
- •9. Medication:
- •9.1. Non-steroid anti-inflammatory drugs (NSAIDs)
- •9.2. Clopidogrel
- •9.3. Antimicrobial medication
- •9.4. Thyroid inhibitors
- •9.5. Serotonin-specific reuptake inhibitor (SSRI?s)
- •9.6. Hb levels < 7.5 mmol/l for women, < 8.4 mmol/l for men
研究者
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