Safety & Results of Peroperative and Intraoperative Intravenous Tranexamic Acid in Diabetic Macular Tractional Retinal Detachment Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Number of systemic adverse events
研究概览
简要总结
The goal of this observational study is to learn about safety and results of peroperative and intraoperative intravenous Tranexamic acid for diabetic macular tractional detachment eye surgeries . The main question it aims to answer is:
Adverse events and their frequency? immediate postoperative bleeding incidence? effective vitrectomy time?
详细描述
all Patients who agreed and gave informed consent forsurgery as well as to be included in study were included
Patients injected INTRAVENOUS TRANEXAMIC ACID 500 mg diluted to 10 ml with normal saline slowly in immediate preoperative period Accordingly, whenever bleeding was anticipated before removing active taut membranes or when bleeder was noted TXA 0.5 g was added upto maximum of 2 g. In Chronic kidney Disease patients dose was kept as maximum of 1.5 g
data analysis pack of microsoft excel will be used for statistical analysis. descriptive statistics will be applied. wherever mean of continuous variables is to be compared among subgroups, unpaired students t test will be used. To find any relationship among continuous variables , pearsons correlation or multiple regression will be used from data analysis pack of microsoft excel.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eyes of Diabetic patients having Macular Tractional Retinal detachment confirmed on Indirect Ophthalmoscope or B scan when associated with Vitreous hemorrhage or Optical Coherence Tomography
排除标准
- •Pregnancy, lactation, Oral Contraceptive use, within 6 months thromboembolic disease ,Underlying cardiac arrhythmia where anticoagulation is indicated ,Seizures Severe liver disease,previous history of variceal bleeding ,Allergic history to Tranexamic acid
- •Ophthalmic exclusion criteria Previous vitreoretinal surgery Combination of tractional and rhegmatogenous retinal detachment Coexisting macular hole Macular dystrophies Arterial or venous occlusions Age related macular degeneration Extensive macular scarring Posterior segment inflammation
结局指标
主要结局
Number of systemic adverse events
时间窗: intraoperatively and postoperatively 24 hours
Safety of intravenous tranexamic acid
次要结局
- Surgical time for vitrectomy(intraoperatively)
- Number of surgeries in which retinectomy required(intraoperatively)
- Number of surgeries in which Perfluorocarbon liquid had to be used(intraoperatively)
- Number of systemic adverse events in patients having Chronic kidney disease(intraoperatively and postoperatively 24 hours)
- Any relation between intraoperative use of Tranexamic acid and labetalol(intraoperatively)
- Number of vitrectomies converted intraoperatively to bimanual technique(intraoperatively)
- Number of surgeries in which Internal Limiting Membrane peeling done(intraoperatively)
- Number of eyes having preretinal bleed at the end of surgery(immediate postoperatively)
- Visual acuity change after surgery(6 months postoperatively)
研究者
Dr. Saurav Mahajan
Director Retina
Ahalia Foundation Eye Hospital