EUCTR2016-003661-26-GB进行中（未招募）1 期
A controlled, randomized, multi-centre, double blind, phase II study to evaluate efficacy and safety of topical PeproStat in intraoperative surgical haemostasis - CLOTFAST 2
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
- 214
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
入选标准
- •1.Subject is undergoing a planned open liver/soft tissue surgery, vascular surgery or spine surgery.
- •2.Subjects are able and willing to provide written informed consent to participate in this study.
- •3.Adult males and females =18 years of age at screening.
- •4.Willing and able to comply with all protocol requirements including follow-up assessments.
- •5.Male subjects must be willing and able to use adequate contraception from enrollment through to the 30 day follow-up visit.
- •6.Women of childbearing potential (WCBP) have to use highly effective methods of contraception from enrollment through to the 30 day follow-up visit. Such methods include:
- •Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal or transdermal.
- •Progestogen-only hormonal contraception associated with inhibition of
- •ovulation: oral, injectable or implantable.
- •Intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, sexual abstinence
- •7.The subject presents an identified target bleeding site with mild or moderate bleeding, which conventional surgical techniques are insufficient to control or are inappropriate and would otherwise be a candidate for standard haemostats.
- •8.The subject presents no intraoperative complications, other than bleeding, that may interfere with study assessments as judged by the Investigator.
- •9.The subject presents no contaminated areas of the body, signs of infection or abscess development.
- •10. Total target bleeding site surface area of = 70 cm2, defined within one or two TBSs
- •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 210
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •1.Subject is undergoing emergency surgical procedure.
- •2.Use of study treatment and sponge in
- •Closure of skin incisions as the sponge may interfere with the healing of skin edges.
- •Intravascular compartments because of the risk of embolization following sponge application.
- •3.Recipient of an organ transplant.
- •4.Haematologic, biochemistry and coagulation panel thresholds at screening:
- •Haemoglobin = 9.0 g/dL.
- •Platelet count =100,000/mm3 (= 100 x 109/L).
- •International Normalized Ratio (INR) > 2.0 or aPTT ratio > 2.0.
- •Fibrinogen level < 1.5 g/L.
- •Aspartate Aminotransferase (AST) or Alanine aminotransferase (ALT) = 3 times the upper limit normal range, except for subjects undergoing liver resection surgery where there is no upper limit for these analytes due to the nature of their disease.
- •5.Severe renal failure.
- •6.Any other disease or condition that may affect normal blood clotting, for example thrombocytopenia, as judged by the Investigator.
- •7.A known history of anaphylaxis or allergic reaction to human albumin, PEGylated proteins, yeast or moulds, porcine products or other components in the study medication or sponge.
- •8.Participation in another investigational drug or device research study within 30 days before and after enrolment in the current study.
- •9.Current known or suspected alcohol and/or drug abuse or dependence at the time of screening.
- •10.Any concurrent medical, surgical, or psychiatric condition that may, in the Investigator’s opinion, affect the subject’s willingness or ability to meet all study requirements during the study duration.
- •11.Known HIV, HBV or HCV infection.
- •12.During the surgery, subject presents severe bleeding where use of a topical haemostat would be inappropriate.
- •13.Anti-platelets/oral anticoagulants treatment:
- •a.Soft tissue/liver and neurosurgery: Subject is taking anti-platelet agents or oral anticoagulants within 7 days of surgery.
- •b.Vascular surgery: Subject is taking dual anti-platelet treatment or oral anticoagulants within 7 days of surgery. One anti-platelet agent is allowed perioperatively.
- •14.Heparin treatment:
- •a.Soft tissue/liver and neurosurgery only: Subject is receiving therapeutic doses of heparin perioperatively. Only prophylactic LMWH is allowed.
- •15.Pregnant or breast-feeding subject.
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