CTRI/2021/09/036977已完成3 期
A Prospective, Randomized, Active Controlled, Observer-blind Clinical Study Evaluating the Safety and Hemostat Efficacy of Absorbable Hemostat Powder of Lucktin (Hainan) Biotech Co., Ltd., in comparison with AristaTM AH (Absorbable Hemostat) of Davol, Inc., Subsidiary of C. R. Bard, Inc. in Mild or Moderate Parenchymal or Soft Tissue Bleeding During General Surgery - Not Applicable
ucktin Hainan Biotech Co Ltd0 个研究点目标入组 360 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 360
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
入选标准
- •I.Pre-operative
- •1.Male or female subjects aged from 18 to 60 years (both inclusive) requiring elective/non-emergent general surgical procedures (minimally invasive surgery or open surgery).
- •2.Subject or legally authorized representative has signed the Ethics Committee approved Informed Consent.
- •3.Subject whose International Normalized Ratio is <1.5 within 24 hours of surgery.
- •4.The subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations.
- •II.Intra-operative
- •1.Presence of an appropriate target bleeding site (TBS) identified intra-operatively by the surgeon.
- •2.Subject(s) on anticoagulation undergoing surgery must have anticoagulation reversed prior to target bleeding site (TBS) identification and treatment.
排除标准
- •I.Pre-operative
- •1.Female subjects who are pregnant or nursing;
- •2.Subject on anticoagulation medication (with the exception of aspirin) prior to surgery. Washout periods for respective medications must be observed. If information is not readily available within the Instructions for Use (IFU), a conservative approach should be taken and intravenous heparin stopped 12 hours prior to surgery and 2 days prior for oral medication;
- •3.Subject on antiplatelet/P2Y12 inhibitors medication prior to surgery. Platelet recovery times for respective medication must be observed. If information is not readily available within the IFU, a conservative approach should be taken and medication stopped 5 days prior to surgery.
- •4.Subject is currently participating or plans to participate in any other investigational device or drug trial without prior approval from the Sponsor;
- •5.Subjects who are known, current alcohol and/or drug abusers
- •6.Subjects with any pre-operative findings identified by the surgeon that may preclude conduct of the study procedure.
- •7.Subjects requiring neurological and ophthalmic procedures.
- •8.Subjects with post-partum bleeding or menorrhagia, uncontrolled hypertensive and diabetic patients.
- •9.History of blood dyscrasias or immunocompromised patients.
- •10.Known ongoing infection (local or systemic).
- •11.Subjects with known psychiatric disorder which would preclude him/her from completing the study.
- •12.Subjects with known congenital or acquired immunodeficiency.
- •II.Intra-operative
- •1.Subjects with any intra-operative findings identified by the surgeon that may preclude the use of study device;
- •2.Subject with target bleeding site (TBS) in an actively infected field [Class III Contaminated or Class IV Dirty or Infected];
- •3.Target bleeding site (TBS) is on arteries or veins where application of absorbable hemostat powder would present a risk of introducing the study device into an open blood vessel;
- •4.Major arterial or venous bleeding or major defects in arteries and veins;
- •5.Target bleeding site (TBS) where silver nitrate or any other escharotic chemicals have been applied, Target bleeding site (TBS) is in, around, or in proximity to foramina in bone, or areas of bony confine, the spinal cord, or optic nerve and chiasm;
- •6.Target bleeding site (TBS) in urological procedures where plugging (blocking) of the urethra, ureter or a catheter is possible by the study device.
研究者
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