Tranexamic Acid for The Management of Bleeding Gastrointestinal Angioectasias: A Randomized, Placebo Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of participants with improved hemoglobin concentrations and/or blood transfusions requirement
研究概览
简要总结
The goal of this clinical trial is to learn if oral tranexamic acid works to treat gastrointestinal angioectasias. It will also learn about the safety of tranexamic acid. The main questions it aims to answer are:
Does tranexamic improve hemoglobin concentration and/or requirement for blood transfusions
What medical problems do participants have when taking tranexamic acid?
Researchers will compare tranexamic acid to a placebo (a look-alike substance that contains no drug) to see if it works to treat angioectasias.
Participants will:
Take tranexamic acid or a placebo three times per day, every day for 3 months Visit the clinic once per month for checkups and tests
详细描述
Currently, the mainstay of treatment for intestinal angioectasias (AEs) includes endoscopic ablation combined with octreotide and iron supplementation. However, many patients continue to suffer from persistent or recurrent symptomatic anemia and often require repeated hospitalizations for blood transfusions. Tranexamic acid (TXA) is a hemostatic agent that has the potential to be beneficial in patients with small bowel gastrointestinal bleeding. Through a literature review multiple case reports have highlighted the impact TXA treatment can have on patients with intestinal AEs. This study would help determine the potential additive effect of TXA in patients with symptomatic anemia due to gastrointestinal AEs. Further, the researchers seek to expand the applications of TXA with the goal of decreasing morbidity and mortality.
In the randomized control trial portion of the study, the researchers will enroll approximately 50 patients with diagnosed intestinal AEs through video capsule endoscopy and/or endoscopy who experience symptomatic anemia despite standard therapy including endoscopic ablation and iron supplementation. Subjects will be randomized to either the TXA treatment group versus the placebo treatment group for 3 months. Patients will have initial complete blood counts (CBC) measured as a baseline then subsequent CBCs measured at 1, 2 and 3 months. Patients will be monitored for drug side effects, symptoms related to anemia, the need for blood transfusions and hospitalizations related to gastrointestinal bleeding/anemia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male, female, non-gender conforming patients aged >18 years with symptomatic anemia attributed to chronic gastrointestinal blood loss from angioectasias despite endoscopic ablation and iron therapy
- •Stated willingness to comply with all study procedures and availability for the duration of the study
排除标准
- •Contraindications to tranexamic acid (TXA) therapy
- •Allergy to TXA, intracranial bleed, history of venous or arterial thromboembolism, active thromboembolic disease, ischemic retinopathy
- •Bleeding/Coagulopathy disorder and/or on anticoagulation regimen
- •Ulcerative colitis or Crohn's disease
- •End stage renal disease
- •Decompensated cirrhosis
- •Pregnancy or intention to become pregnant
- •Patient refusal of blood products because the secondary outcome is pre-determined
- •Unable to give formal consent
- •Participation in another interventional study where primary outcome includes hemoglobin/hematocrit values
- •Inability to adhere to treatment regimen for 3 months
- •Non-English speaking
- •Patients < 18 years old
研究组 & 干预措施
Tranexamic Acid
Patients randomized to the interventional arm will take oral tranexamic acid 650 mg three times per day for 3 months. They will have blood work drawn every month for the 3 month trial period.
干预措施: Tranexamic Acid (TXA) treatment (Drug)
Placebo
Patients randomized to the placebo comparator arm will take oral placebo medication three times per day for 3 months. They will have blood work drawn every month for the 3 month trial period.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with improved hemoglobin concentrations and/or blood transfusions requirement
时间窗: From enrollment to the end of treatment at 3 months
To determine whether oral therapy with tranexamic results in improvement in serum hemoglobin concentration and/or requirement for blood transfusion compared to placebo in patients treated with standard endoscopic ablation and iron supplementation
次要结局
- Number of Participants with Treatment-Related Adverse Events(From enrollment to the end of treatment at 3 months)