NL-OMON33792招募中2 期
A prospective, non-controlled, open-label study to assess the safety and effectiveness of Fibrocaps* in subjects undergoing liver resection. - FC-001-Liver resection
ProFibrix0 个研究点目标入组 10 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Signed the written informed consent form before first screening procedure;
- •2. Males and females aged >= 18 years and <= 75 years;
- •3. Scheduled to undergo open liver resection for any reason except trauma;
- •4. Uses adequate contraception during the course of the study
- •5. Has a life expectancy of at least one year.
- •6. Has a normal liver background (absence of extensive fibrosis and cirrhosis)
- •Intraoperative Inclusion Criteria:
- •7. Presence of mild or moderate bleeding/oozing which control by conventional surgical techniques, including but not limited to suture, ligature and cautery is ineffective or impractical;
- •8. Absence of intra-operative complications other than bleeding at the resection site which may, in the opinion of the investigator, interfere with assessment of effectiveness or safety.
排除标准
- •1. Pregnant or lactating women and women planning to become pregnant in the 3 months after surgery;
- •2. Has a known intolerance to blood products or to Fibrocaps components;
- •3. Unwilling to receive human blood products;
- •4. Has any psychiatric problems, in the opinion of the investigator, likely to invalidate informed consent;
- •5. Has a mental or physical condition that would, in the opinion of the investigator, place the subject at an unacceptable risk or render the subject unable to meet the requirements of the protocol;
- •6. Unwilling and/or unable to comply with all aspects of the protocol for the duration of the study;
- •7. a) currently participating or b) has participated in another clinical study involving another IMP within 4 weeks of the start of this trial or c) is planning participation in another clinical trial in the 4 weeks after surgery, which in the opinion of the investigator may interfere with assessment of effectiveness or safety.;
- •8. Has any other known coagulation disorder which may interfere with the assessment of effectiveness according to the investigator;
- •9. Child Pugh score B or C;
- •10. ASAT and/or ALAT > 3 x upper limit normal range;
- •11. Thrombocytopenia, < 100 x109 PLT/L;
- •12. APTT > 100 seconds;
- •13. INR > 2 x upper limit normal range;
- •14. Use of anticoagulant therapy other than routine prophylaxis for DVT, use of platelet aggregation inhibitors, thrombolytics or anticipated use of these agents after surgery.
- •15. Treatment with cyclosporine
- •16. Healthy donors scheduled to undergo liver resection for transplantation purposes.
研究者
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