TRanEXamic Acid to Decrease Heavy Menstrual Bleeding in Individuals Anticoagulated for Venous Thromboembolism Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Participant recruitment to study
研究概览
简要总结
T-REX HMB is a pilot randomized controlled trial (RCT) designed to assess the feasibility of a full trial comparing tranexamic acid (TXA) to placebo in decreasing HMB in premenopausal individuals anticoagulated for VTE. Strong data supports TXA as an effective and safe agent at decreasing HMB in the general population, but its use in those with VTE has been limited by a lack of data for its efficacy in anticoagulated individuals and theoretical concerns of its prothrombotic effects.
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 (Outcomes Assessor)
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
- •Adult pre-menopausal individuals with regular menstrual cycles (defined as menstrual bleeding every 24 to 38 days)
- •Diagnosed with acute VTE on objective imaging;
- •Within two weeks of starting treatment with therapeutic dose anticoagulation;
- •Planned treatment of at least 3 months of therapeutic dose anticoagulation.
- •Written informed consent in accordance with federal, local and institutional guidelines.
排除标准
- •Hypersensitivity or allergy to TXA
- •Active major bleeding other than menstrual bleeding
- •Use of hormonal contraceptives
- •Known history of thrombosis and antiphospholipid syndrome (including those patients that are triple positive for lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein I antibodies.
- •Known renal insufficiency
- •Pregnant or breastfeeding
- •Use of other thrombotic agents
- •Under 18 years of age
- •Patient is unable to provide informed consent (lacking capacity, language etc)
研究组 & 干预措施
Tranexamic acid
Tranexamic acid (Cyclokapron®) 1.5 grams, orally, three times a day during menstrual cycle for the 3 month study period.
干预措施: Tranexamic acid (Drug)
No tranexamic acid
Routine clinical care without Tranexamic acid
干预措施: No Tranexamic acid (Other)
结局指标
主要结局
Participant recruitment to study
时间窗: 3 months
Number of participants successfully recruited to the study and randomized to a treatment arm
次要结局
- Participant compliance with study procedures(3 months)
- Loss to follow-up or drop-out(3 months)
- Participant adherence to the study drug(3 months)
研究者
Jameel Abdulrehman
Staff Hematologist
University Health Network, Toronto