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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 10
- 主要终点
- Proportion of subjects achieving hemostatic success at 5 minutes following the application of powder with no re-bleeding requiring additional treatment at the target bleeding site (TBS) in each group.
研究概览
简要总结
Thiswill be a prospective, parallel design, active controlled, observer-blindmulticenter, clinical study comparatively evaluating absorbable hemostat powderin achieving hemostasis in mild or moderate parenchymal or soft tissue bleedingduring surgery. The main objective of this study is to evaluate the efficacy (as the primary objective) andsafety (as the secondary objective) of the Absorbable Hemostat powder ofLucktin (Hainan) Biotech Co., Ltd., (test device) in comparison with AristaTM AH(Absorbable Hemostat)of Davol, Inc.,Subsidiary of C.R. Bard, Inc. (reference device; active control) in identified mild or moderate softtissue/parenchymal bleeding for which conventional methods of control (e.g.,suture, ligature, and cautery) are ineffective or impractical, and an adjunctdevice is required to achieve hemostasis. Approximately 360 subjectswill be randomized to either test or reference device in a targeted 1:1 ratio.Subjects undergoing open surgery and minimally invasive surgery will beselected in a targeted 2:1 ratio by stratified randomization technique. Thus,approximately 240 subjects will be selected from subjects undergoing opensurgery, and approximately 120 subjects will be selected from subjectsundergoing minimally invasive surgery. The test to reference ratio will bemaintained at 1:1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
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.
- •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.
结局指标
主要结局
Proportion of subjects achieving hemostatic success at 5 minutes following the application of powder with no re-bleeding requiring additional treatment at the target bleeding site (TBS) in each group.
时间窗: Intra-operatively
次要结局
- •Proportion of subjects achieving hemostatic success at 3 minutes following the application of powder with no re-bleeding that requires additional treatment at the TBS in each group.(•Proportion of subjects achieving hemostatic success at 10 minutes following the application of powder with no re-bleeding that requires additional treatment at the TBS in each group.)