Randomized and Controlled Clinical Trial of Transfusional Requirements in Patients With Acute Gastrointestinal Bleeding.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 860
- 试验地点
- 2
- 主要终点
- Mortality at the 45th day
研究概览
简要总结
Recently it has been suggested that a restrictive transfusion of units of Red Cells (URC) may improve the outcome of ICU patients with anemia. Furthermore, it has been suggested that the transfusion of URC may be deleterious for the hemostatic process of bleeding lesions, which suggest that a restrictive transfusion may be valuable in patients which gastrointestinal bleeding. Transfusion of URC may also increase portal pressure which may be detrimental to control acute portal hypertensive bleeding.
The aim of the present study is to assess whether a restrictive transfusions may improve the outcome of patients with acute nonvariceal gastrointestinal bleeding, and also whether such a restrictive strategy may improve the outcome of bleeding episodes related with portal hypertension.
The study will be carried out with a prospective, randomized and controlled design comparing the restrictive transfusion strategy with the usual nonrestrictive transfusional strategy. Overall 860 patients will be included; 430 in each group.
The main outcome measure will be survival. All deaths occurred within the 30 days after admission, will be considered. Secondary outcomes will include rebleeding and complications related to treatment, and related to the bleeding episode itself. Portal pressure will be measured to assess the influence of the transfusions strategy on fluctuations of this parameter, and the relationship with the clinical course of bleeding episode.
The study will be performed at the Bleeding Unit of our hospital during a period of 3 years.
详细描述
HYPOTHESIS
At the present time there does not exist established criteria to decide when it is necessary a blood transfusion in a patient with digestive hemorrhage, neither which should be the red cells concentrates (RBC) amount that the most of the patients will need.
In clinical studies made in critical patients undergoing a by-pass coronary surgery, the strategy of restrictive transfusion showed results similar to the one obtained with more liberal strategies, even with an improvement of the survival and a smaller rate of complications related to transfusion.
In animal models of GI bleeding (and also in human studies in the traumatic hemorrhage), precocious or vigorous transfusion made hemostasia more difficult. Also an increase in the rate of rebleeding has been observed, suggesting that arterial hypotension combined with hypovolemia aid hemostasia, stabilize the clot. It leads to diminish by itself the rebleeding rate.
In the same way, in patients with portal hypertension associated hemorrhage, aggressive replacement of volemia causes increases on the portal pressure, and that could lead in a condition of bigger difficulty for the control of the hemorrhage and greater rate of recidiva.
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
- None
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
- •All patients with acute upper GI hemorrhage who do not have any criterion of exclusion.
排除标准
- •< 18 years old.
- •Pregnancy.
- •Negative of the patient to receive transfusions.
- •Negative of the patient to participate in the study.
- •Patients with therapeutic restrictions (as terminally ill patients).
- •Previous recent surgery requiring transfusion.
- •Recent (less than 90 days) or unstable acute myocardic ischemia. Peripheral vasculopathy with secondary.
- •To have been included in this same study in the 30 previous days.
结局指标
主要结局
Mortality at the 45th day
时间窗: 45 days
次要结局
- Mortality at the 7th and 45th day(45 days)
- Rebleeding(45 days)
- Transfusion requirements(45 days)
- Liquids requirements(45 days)
- Portal pressure changes(7 days)
- Complications(45 days)