The Role of Tranexamic Acid for the Treatment of Gastrointestinal Bleeding: A Randomized Double-blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 336
- 试验地点
- 1
- 主要终点
- Re-bleeding
研究概览
简要总结
Studies showed that in cases of gastrointestinal bleeding, injection tranexamic acid decreasing the risk of death and the need of surgical intervention. However, the quality of most clinical trials were not good and the results were not significant. Injection tranexamic acid does not become one of the treatment option in the international guidelines nor in national consensus, so the effectiveness and the safety of its use in the treatment of gastrointestinal bleeding remains unclear and not routinely used.
In Indonesia, injection tranexamic acid in gastrointestinal bleeding is limitedly used and recorded. Therefore, a clinical trial study of injection tranexamic acid is required to assess the effectiveness and the safety in the treatment of gastrointestinal bleeding.
详细描述
This study is a randomized double-blind controlled trial study. Interventions were given in the form of tranexamic acid injection compared to placebo in patients with acute upper and lower gastrointestinal bleeding. Tranexamic acid were administered intravenously 1 gram loading dose, followed by 3 grams maintenance dose in infusion for 24 hours. Other routine and standardized drugs for gastrointestinal bleeding will still be given. Statistical analysis will use: Chi square test or Kolmogorov-Smirnov with alternative Fisher test for categorical dependent-variable; Independent T-Test with alternative Mann-Whitney test for two-group numerical dependent-variable; and one-way ANOVA with alternative Kruskal-Wallis for more than two-groups numerical dependent-variable.
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
- Single (Participant)
盲法说明
All patients will receive standard treatment equally
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
- •Patients with acute lower and upper gastrointestinal bleeding (assessed clinically)
- •Patients agreed to participate in the study and signed the informed consent
排除标准
- •Allergy with tranexamic acid
- •Patients considered by the clinician can not be randomized to participate in the study
- •Patients with chronic kidney disease stage III - V
研究组 & 干预措施
Tranexamic acid injection
Group with tranexamic acid injection
干预措施: Tranexamic acid injection (Drug)
Placebo
Group with Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Re-bleeding
时间窗: 30 days after randomisation
Total incidence number of re-bleeding
次要结局
- Length of stay in intensive care unit(30 days after randomisation)
- Need for endoscopic hemostasis(30 days after randomisation)
- Need for blood transfusion(30 days after randomisation)
- Level of anxiety(30 days after randomisation)
- Number of death(30 days after randomisation)
- Quality of life (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health)(30 days after randomisation)
研究者
Ari Fahrial Syam
Medical Doctor, Gastroenterology Hepatology Consultant
Indonesia University