EUCTR2011-006174-47-NL进行中（未招募）不适用
A Phase 3, Randomized, Single-Blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Haemostasis - FINISH-3
ProFibrix Inc.0 个研究点目标入组 672 人开始时间: 2012年5月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 672
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
- •Inclusion Criteria (pre-surgery):
- •1. Subject has signed an institutional review board/independent ethics committee
- •(IRB/IEC)-approved informed consent document
- •2. Subject is undergoing one of the surgical procedures described above
- •3. Subject age is =18 years at time of consent
- •4. If female and of child-bearing potential, subject has negative pregnancy test during screening and is not breast-feeding.
- •5. If subject is a sexually active male or a sexually active female of child-bearing
- •potential, subject agrees to use a medically accepted form of contraception from the
- •time of consent to completion of all follow-up study visits
- •Inclusion Criteria (during surgery):
- •1. Subject has not received blood transfusion between screening and study treatment.
- •2. Presence of mild or moderate bleeding/oozing when control by conventional surgical
- •techniques, including but not limited to suture, ligature and cautery is ineffective or impractical.
- •3. Absence of intra-operative complications other than bleeding which, in the opinion of the Investigator, may interfere with the assessment of efficacy or safety.
- •4. No intra-operative use of a topical hemostat containing thrombin prior to study treatment.
- •5. Approximate TBS surface area of = 100 cm2
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 404
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 268
排除标准
- •Exclusion Criteria:
- •1. Subject has known antibodies or hypersensitivity to thrombin or other coagulation
- •2. Subject has history of heparin-induced thrombocytopenia (only for vascular subjects
- •where heparin use is required)
- •3. Subject has known allergy to porcine gelatin
- •4. Subject is unwilling to receive blood products
- •5. Has any clinically-significant coagulation disorder that may interfere with the
- •assessment of efficacy or pose a safety risk to the subject according to the Investigator,
- •or baseline abnormalities of INR > 2.5 or aPTT > 100 seconds during screening that
- •are not explained by current drug treatment (e.g., warfarin, heparin)
- •6. Aspartate Aminotransferase (ASAT/AST ) or Alanine aminotransferase (ALAT/ALT)
- •> 3 x upper limit normal range during screening, except for subjects undergoing liver
- •resection surgery or with a diagnosis of liver metastases where there is no upper limit
- •for these analytes due to the nature of their disease
- •7. Platelets < 100 x109 PLT/L during screening
- •8. Subject has medical, social or psychosocial factors that, in the opinion of the
- •Investigator, could impact safety or compliance with study procedures
- •9. Subject is currently participating or has participated in another clinical study involving
- •another investigational agent within 4 weeks of the planned date of surgery or is
- •planning participation in another clinical trial within 4 weeks after surgery
研究者
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