Liberal Versus Restrictive Transfusion Management in Patients Being Weaned From Prolonged Mechanical Ventilation
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Time to sucessfull weaning
研究概览
简要总结
The aim of this study is to determine, whether a liberal transfusion strategy is helpful to liberate patients from prolonged invasive mechanical ventilation.
Patients who are difficult to wean according to the criteria by Boles et al [1] are limited by the capacity of their respiratory muscles.
Improved oxygen delivery achieved by blood transfusions however is known to decrease the work of breathing [2] and thus in theory can improve weaning success [3].
This study is designed as a prospective, randomized, open labeled blinded End-point evaluation to test the hypothesis that a liberal transfusion strategy decreases the time needed for weaning.
- Boles, JM, J Bion, A Connors, M Herridge, B Marsh, C Melot, R Pearl, H Silverman, M Stanchina, A Vieillard-BaronandT Welte, Weaning from mechanical ventilation. Eur Respir J, 2007. 29(5): p. 1033.
- Schonhofer, B, M Wenzel, M GeibelandD Kohler, Blood transfusion and lung function in chronically anemic patients with severe chronic obstructive pulmonary disease. Crit Care Med, 1998. 26(11): p. 1824.
- Schonhofer, B, H BohrerandD Kohler, Blood transfusion facilitating difficult weaning from the ventilator. Anaesthesia, 1998. 53(2): p. 181.
详细描述
Liberation from invasive mechanical ventilation has a huge impact on quality of life and healthcare expenses. Weaning is more difficult and complex in patients who have been ventilated for a longer time (i.e. more than seven days) or have undergone multiple failed weaning attempts and thus are classified weaning category three according to Boles at al. [1] Current national and international guidelines are in favour of a rather restrictive transfusion regime. This recommendation is mainly based on the work of Hebert et al. [2] where no benefit or a liberal transfusion approach could be found. Patients in the Hebert study however had become acutely ill and did not show any impairment or dysfunction of the respiratory muscles
Weaning class 3 patients however suffer from an overload of their respiratory muscles either cause by an increased load or decreased capacity.
In either instance unloading of the respiratory muscles is key to improve the capability of spontaneous breathing. One possible way to achieve this goal is to improve oxygen delivery.
Oxygen delivery is determined by the cardiac output times the oxygen content of the blood. The latter is mainly determined by the haemoglobin concentration and the oxygen saturation (Hb x 1.34 x SaO2 + PO2 x 0.003). Previous studies have shown that in patients with a strained respiratory pump blood transfusions improve the work of breathing [3].
A more liberal transfusion strategy therefore might improve the weaning outcome ventilator dependant patients [4]
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
- •Hb < 9g/dl
- •Prolonged mechanical ventilation for > 14 days
- •Hemodynamically stable / no acute ongoing disease
- •weainingfailure
- •spontaneous breathing capacity less than four hours
- •Euvolemia
排除标准
- •Age < 18 years
- •Pregnancy
- •known blood incompatibility
- •acute indications to give blood products or previous transfusions within the last three days
- •previously known chronic anemia
- •ongoing dialysis
结局指标
主要结局
Time to sucessfull weaning
时间窗: 14 days
Time between randomisation an sucessfull liberation from invasive mechanical ventilation
次要结局
- mortality(within hospital)