EUCTR2011-006174-47-GB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28日最近更新:
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
- •The study will enroll subjects undergoing one of the surgical procedures defined below who have mild to moderate bleeding requiring the use of a topical hemostat.
- •1. Spinal surgery
- •Cervical, thoracic, or lumbar discectomy, corpectomy, laminectomy, lateral or interbody fusion. Epidural bleeding typically described as oozing, flowing, or pulsatile, and normally requiring topical adjuncts to hemostasis is necessary to be considered eligible.
- •The TBS may not be within a bony cavity or other confined area.
- •2. Vascular Surgery
- •All subjects undergoing vascular surgery should be systemically heparinized according to
- •standard procedures. The clamp(s) should be removed to determine if an appropriate TBS with mild to moderate bleeding is present. The clamps should remain off once a TBS is identified and during the treatment and assessment of TTH. If protamine reversal is indicated, it should occur after the 5-minute TTH assessment period is completed, unless a safety concern dictates that it should happen earlier.
- •a. Arterial bypass surgery
- •Arterial bypass with an artificial graft (i.e., PTFE or Dacron) including patching and revision procedures, and abdominal aorta aneurysm (AAA) repair. Anastomotic sites at the proximal end of the graft, the distal end of the graft (AAA repair ONLY) or on the suture line of the patch will be available for TTH measurement. The allowed vessels include those of the extremities and the abdominal aorta.
- •b. Arteriovenous graft formation for hemodialysis access
- •Artificial graft (i.e., PTFE or Dacron) for hemodialysis access, including revision procedures. Anastomotic sites only at the arterial end of the graft will be available for TTH measurement.
- •c. Carotid endarterectomy
- •Carotid endarterectomy requiring a Dacron patch, where the suture line of the patch will be used for TTH assessment.
- •3. Hepatic resection
- •Hepatic wedge resection or anatomic resection of 1 to 5 contiguous hepatic segments, which may be combined with surgical procedures involving the pancreas, gall bladder, bile duct or intestines. Subjects undergoing living-related liver donation are also eligible.
- •4. Soft tissue dissection
- •The TBS will be identified during the soft tissue dissection related to the primary operative procedure. Primary operative procedures include but are not limited to: abdominoplasty, lower anterior resections, abdominal perineal resections, distal pancreatectomy, esophagectomy, donor skin graft site in limited burn patients, and mastectomy.
- •Appropriate soft tissue types will include but will not be limited to: loose areolar tissue, fat, lymphatic tissue/lymph node beds, and muscle. The TBS will not involve parenchymal, vascular (anastomotic or vascular repair sites), gastrointestinal or genitourinary soft tissue.
- •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 bl
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
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