A Phase 3, Randomized, Single-Blind, Controlled Trial of Topical Fibrocaps* in Intraoperative Surgical Haemostasis - FINISH-3

ProFibrix0 个研究点目标入组 180 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•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 Confidential
•4. No intra-operative use of a topical hemostat containing thrombin prior to study treatment
•5. Approximate TBS surface area of <= 100 cm2

•Exclusion Criteria:
•1. Subject has known antibodies or hypersensitivity to thrombin or other coagulation factors
•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

发起方

ProFibrix