Efficacy of Tranexamic Acid and Vitamin K Injection in Control of Upper Gastrointestinal Bleeding in Egyptian Cirrhotic Patients: a Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Rebleeding rate
研究概览
简要总结
The goal of this randomized controlled clinical trial is to evaluate the efficacy of Tranexamic acid and vitamin K injection versus placebo in control of upper gastrointestinal bleeding (UGIB) in Egyptian cirrhotic patients.
Researchers will compare the bleeding and mortality rates (at 5 days and 6 weeks post endoscopic intervention for UGIB) between patients receiving tranxemic acid and vitamin K injection and patients receiving placebo.
Participants presenting with variceal bleeding will be randomly assigned to receive tranexamic acid (1 g loading dose followed by 3 g maintenance dose over 24- 48 hours) and intravenous injection of 10 mg daily of vitamin K for 24-48 h or matching placebo group receiving IV saline. Intervention will be carried out besides the recommended initial management of airway management, hemodynamic stabilization, octreotide analogue, PPI, antibiotics, and endoscopy.
Follow-up All patients will be kept at the hospital for at least 5 days from the index bleed and will be discharged if no other reason was observed to keep them at the hospital.
The rate of rebleeding, need for blood transfusion, hospital stay, adverse effects, and mortality rate were evaluated and compared across the groups.
At discharge, all patients will be started on nonselective beta-blockers if there was no contraindication. They will be given instructions to attend to hospital if they noticed any melena or hematemesis.
Second follow-up after 6 weeks for the rebleeding rate and mortality related to bleeding rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Liver cirrhosis
- •Upper gastrointestinal bleeding
排除标准
- •Patients aged < 18 years
- •Allergy to tranexamic acid
- •Allergy to vitamin K injection
- •Thromboembolic event.
- •Pregnancy or lactation.
- •End-stage renal disease.
- •Unwilling to participate in our study.
研究组 & 干预措施
Tranexamic acid and vitamin K
97 cirrhotic patients presenting with UGIB receiving tranexamic acid (1 g loading dose followed by 3 g maintenance dose over 24-48 hours) and intravenous injection of 10 mg daily of vitamin K for 24-48 h. Intervention will be carried out besides the recommended initial management of airway management, hemodynamic stabilization, octreotide analogue, PPI, antibiotics, and endoscopy.
干预措施: Tranexamic Acid and vitamin K (Drug)
Placebo
97 cirrhotic patients presenting with UGIB receiving IV saline besides the recommended initial management of airway management, hemodynamic stabilization, octreotide analogue, PPI, antibiotics, and endoscopy.
干预措施: Placebo (Drug)
结局指标
主要结局
Rebleeding rate
时间窗: through study completion, an average of 1 year
The rate of rebleeding and need for blood transfusion at 5 days and 6 weeks will be evaluated and compared across the groups.
次要结局
- Mortality rate(through study completion, an average of 1 year)
- adverse effects(through study completion, an average of 1 year)
研究者
Rania Mamdouh Elkafoury
Lecturer of Tropical Medicine
Tanta University