Liberal Versus Restrictive Transfusion During Symptomatic Moderate Anemia After Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Postoperative Dizziness scale
研究概览
简要总结
The purpose of this study is to evaluate the effects of transfusion of red blood cells in treating postoperative dizziness in patients with moderate postoperative anemia after total hip arthroplasty.
详细描述
Hip arthroplasty is associated with bleeding and postoperative anemia. However, the optimal strategy for transfusing red blood cells (RBC) remains to be elucidated. Postoperative anemia may cause dizziness and fatigue which delays early mobilization after surgery and may trigger the transfusion of one or more RBC units. However, it is not known whether the administration of 1-2 units of RBC to patients suffering from moderate postoperative anemia (HB 7.5 - 10 g/dl) will improve postoperative dizziness.
Thus, this randomized controlled study aims to evaluate whether the administration of 1-2 RBC units on the first postoperative day improves postoperative dizziness in patients undergoing total hip arthroplasty.
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, Investigator, Outcomes Assessor)
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
- •Age > 18 and able to give consent
- •Hip arthroplasty or hip revision arthroplasty
- •Haemoglobin > 4.8 mmol/L and < 6.0 mmol/L on the first postoperative day
- •Dizziness score ≥ 2.
排除标准
- •Large ongoing bleeding
- •Has already received RBC during the current admission
- •New onset of cardiac arrhythmia suspected to be related to anemia
- •Severe ischemic heart disease
- •Renal failure with dialyses or oligouria / anuria.
研究组 & 干预措施
RBC transfusion
Administration of up to 2 RBC units on the first postoperative day.
(1 unit at a time followed by evaluation of the primary outcome measure)
干预措施: Red blood cell transfusion (Other)
Restrictive: Colloid infusion
Infusion of up to 2 x 280 ml colloid (6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride). 280 ml at a time. Evaluation of primary outcome after each intervention.
干预措施: Voluven (Drug)
结局指标
主要结局
Postoperative Dizziness scale
时间窗: Day 1 after surgery
Dizziness scale (0-3) evaluated by the study nurse. The scale is evaluated upon information on the 1) severeness of dizziness AND 2) it´s consequenses for early mobilization after surgery. 0 - No dizziness. 1. - Light dizziness / No consequences for mobilization 2. - Moderate dizziness / Only shorter periods of mobilization possible 3. - Severe dizziness / No or only short bedside mobilization possible
次要结局
- Timed up and go test (TUG)(Day 1 after surgery and on the day of discharge (expected mean 4 days after surgery))
- Fatigue score(Day 1 after surgery and on the day of discharge (expected mean 4 days after surgery))
- FACT-Anemia scale(7 and 14 days)
研究者
Oeivind Jans
M.D, Clinical Assitant
Rigshospitalet, Denmark