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临床试验/NCT04188184
NCT04188184已完成不适用

Topical Use of Tranexamic Acid Versus Epinephrine to Optimize Surgical Field During Exploratory Tympanotomy

Assiut University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年12月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
State of surgical field categorized by surgeons based on Boezaart classification

研究概览

简要总结

Exploratory tympanotomy is surgical access to the middle ear, made for diagnosis and management of unexplained conductive hearing loss, performed under an oto-microscope across the external auditory canal after tympanic membrane elevation to explore the middle ear structures

详细描述

Epinephrine is a vasoconstrictor searched intensively for ptimization of the surgical field during microscopic ear and sinus surgeries with controversial results given the possible cardiovascular complication in case of systemic absorption,especially in vulnerable cardiac patients.Tranexamic acid (TXA) as an antifibrinolytic medication is used to treat or prevent excessive bleeding in significant trauma, surgery, tooth removal, or nasal bleeding, discovered by Japanese researchers. TXA, given either oral or intravenous, is a derivative of lysine amino acid; it acts reversibly on the lysine binding sites to block it on the plasminogen molecules. TXA consequently hinders the stimulation of plasminogen competitively, thus reduces its conversion into plasmin. Plasminogen is the enzyme that leads to the degradation of a fibrin clot, fibrinogen, and other plasma proteins, such as factors V and VIII. More than 95% of TXA intravenous administered dose eliminated unchanged through the urinary system. Twenty-four hours after intravenous administration of TXA has demonstrated accumulative excretion of approximately 90%, whereas only 3% is bound to plasminogen. TXA is minimally excreted in breast milk while it can freely cross the blood brain barrier and the placenta .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18 - 60 years old
  • ASA (I and II)
  • Hb level > 10 mg/dl
  • elective ear exploratory tympanotomy surgery under general anesthesia.

排除标准

  • Allergy to TXA
  • bleeding/coagulation disorders
  • psychiatric illness
  • acute and chronic renal failure
  • heparin use within 48 hrs or aspirin use within seven days before surgery,
  • pregnancy
  • liver cirrhosis
  • color blindness
  • cardiac stent.

研究组 & 干预措施

tranexmic acid

Active Comparator

received topical 1 gram of TXA diluted in 200 ml of normal saline (0.9%) for topical use to rinse the bleeding sites and soak the used gauze for local compression.

干预措施: Tranexamic Acid (Drug)

Epinephrine roup

Active Comparator

received Epinephrine 1 mg diluted in 200 ml normal saline (0.9%) for topical use to rinse the bleeding sites and soak the used gauze for local compression.

干预措施: Epinephrine (Drug)

结局指标

主要结局

State of surgical field categorized by surgeons based on Boezaart classification

时间窗: 2 hour

Grade Description 0 No bleeding (cadaveric conditions) 1. Slight bleeding: no suctioning required 2. Slight bleeding: occasional suctioning required 3. Slight bleeding: frequent suctioning required, bleeding threatens surgical field a few seconds after suction is removed 4. Moderate bleeding: frequent suctioning required and bleeding threatens surgical field directly after suction is removed 5. Severe bleeding: constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible

次要结局

  • bleeding volume(2 hour)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rasha Hamed

Director

Assiut University

研究点 (2)

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