NL-OMON53880尚未招募不适用
A Prospective, Multicenter, Randomized Clinical Investigation Evaluating the Safety and Efficacy of GATT-Patch Versus TachoSil for Hemostasis During Open Liver Surgery - Safety/efficacy of GATT-Patch vs TachoSil During Open Liver Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Subject is scheduled to undergo elective open surgery on the liver;
- •Subject is willing and able to give written informed consent for the clinical
- •investigation participation;
- •Subjects is 22 years of age or older at the time of enrollment; and
- •Subject has been informed of the nature of the clinical investigation.
- •Subject in whom the Investigator is able to identify a target bleeding site
- •at the liver resection plane for which any applicable conventional means for
- •hemostasis (e.g. suture, ligature or cautery) are ineffective or impractical,
- •and the choice is made to use a hemostatic agent to stop the bleeding; and
- •Subject has a target bleeding site with a SBSS of 1, 2, or 3 (e.g. reflecting
- •minimal, mild or moderate bleeding severities).
排除标准
- •The target bleeding site is from a large defect in an artery or vein that
- •requires vascular reconstruction with maintenance of vessel patency;
- •Subject is scheduled to undergo surgery on other organs than the liver and
- •its associated biliary and vascular system;
- •Subject is scheduled to undergo a staged liver surgery procedure (e.g.,
- •Associating Liver Partition and Portal vein ligation for Staged hepatectomy
- •Subject is taking multiple antithrombotic therapies in therapeutic dosage up
- •to the time of surgery, but allowing exclusive use of acetylsalicylic acid;
- •Subject has platelet count <100 x 109/L, an activated partial thrombin time
- •of >100s, or international normalized ratio >2.5;
- •Subject has a total bilirubin level of >=2.5 mg/dl;
- •Subject is pregnant, planning on becoming pregnant or actively breastfeeding
- •during the 3-month follow-up period;
- •Subject has a known hypersensitivity to brilliant blue (FD&C Blue #1),
- •porcine gelatin, or horse proteins;
- •Subject who has religious objections to receiving products with components of
- •animal (porcine or equine) or human origin;
- •Subject has an active or suspected infection at the bleeding site;
- •Subject in whom the investigational device will be used at the site of a
- •synthetic graft or patch implant;
- •Subject has a life expectancy of less than 3 months;
- •Subject has a documented severe congenital or acquired immunodeficiency;
- •Subject has had or has planned to receive any organ transplantation;
- •Subject is currently participating or has participated in another clinical
- •investigation within the past 30 days that may affect the endpoints of the
- •study, such as trials related to the surgical procedure, and on
- •anti-coagulation;
- •Subject is not appropriate for inclusion in the clinical investigation, per
- •the medical opinion of the Investigator; and
- •Subject has any incidental (pre- and peri-operative) findings deemed by the
- •Investigator to potentially jeopardize the safety or welfare of the subject.
研究者
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