Effect of Tranexamic Acid on Blood Transfusion in Upper Gastrointestinal Bleeding
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Amount of blood transfusions needed (units of packed RBCs)
研究概览
简要总结
The investigators hypothesize that addition of Tranexamic acid, an antifibrinolytic agent, to conventional therapy will lead to an improved outcome characterized by lower transfusion requirements.
详细描述
After informed consent is obtained patients will be randomized to receive either Tranexamic acid or placebo in additional to conventional therapy. All patients with gastrointestinal hemorrhage who are admitted to the ICU are managed in consultation with the GI physicians. The ICU team in consultation with the gastroenterology team will manage these patients. Tranexamic acid will be administered in a dose of 1 gm intravenously every 6 hours for four days.
The majority of patients with GI bleeding will spontaneously stop bleeding. However, in those patients that do not and are hemodynamically unstable it poses a significant management challenge. Management of these individuals includes resuscitation followed by endoscopy as well as therapy guided by clinical diagnosis. With optimal therapy mortality in these individuals remains high and the amount of blood transfusion on occasions turns out to be massive and often the outcomes are futile. Tranexamic acid is an antifibrinolytic agent that has been shown to be associated with reduced bleeding and transfusion requirement in surgical patients. We would like to randomize patients to receive either Tranexamic acid or placebo in addition to conventional therapy and monitor outcome.
This study should provide us with information about the efficacy of this medicine in patients with upper GI bleeding. Data from this trial will provide us information about utility of pursuing this modality of therapy.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with GI bleed if the following criteria are met:
- •has received 4 units of PRBCs within a 24-hour period, or
- •has orthostatic hypotension (drop in SBP of 20mmHg or drop in DBP of 10mmHg after fluid resuscitation with at least 20ml/Kg of either isotonic fluid and/or PRBCs), or
- •if the MAP remains below 60mmHg after fluid resuscitation, and
- •written informed consent is obtained from the subject or legally authorized representative.
排除标准
- •Pregnant or lactating women
- •Known to have gastrointestinal malignancy
- •On anticoagulation therapy
- •Patients with history of thromboembolism
- •Patients with history of myocardial infarction or ischemic cerebrovascular accident
- •Patient with end stage renal disease
- •Patients with DNR status
- •Incarcerated individuals
研究组 & 干预措施
Tranexamic acid arm
干预措施: tranexamic acid (Drug)
Control arm
Will receive a placebo in place of tranexamic acid treatment
干预措施: Placebo (Other)
结局指标
主要结局
Amount of blood transfusions needed (units of packed RBCs)
时间窗: Every 6 months
次要结局
- Rebleeding events(Every 6 months)
- Need for surgical intervention(Every 6 months)
- Mortality rates(Every 6 months)
- Length of stay in ICU(Every 6 months)
研究者
Gary Kinasewitz
Principal Investigator
University of Oklahoma