EUCTR2021-005493-25-CZ进行中（未招募）1 期
Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery: A randomized pilot study (EFISS trial)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age < 18 years of age at the time of enrolment
- •2. Elective scoliosis surgery
- •3. Signed the relevant informed consent form
- •4. Sexually active participants (= 15 years old) must agree to the use of following methods of contraception for the duration of this clinical trial:
- •a) Women - proper use of a highly reliable method of contraception, i.e. combined hormonal contraception (oral, vaginal or transdermal form), gestagen hormonal contraceptives associated with ovulation inhibition (oral or injectable form) or sexual abstinence.
- •b) Men - sexual abstinence or the use of an adequate contraceptive method (i.e. condom) in case of sexual intercourse.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 32
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Diagnosed congenital or acquired coagulopathy
- •2. Use of anticoagulants with the exception of perioperative prophylactic administration of LMWH to prevent VTE
- •3. Known hypersensitivity to the active substance or to any of the excipients of IMP
- •4. History of deep vein thrombosis or pulmonary embolism
- •5. Pregnancy and lactation.
研究者
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