Efficacy of Preoperative Autologous Blood Donation and Tranexamic Acid in Revision Total Hip Arthroplasty: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Number of Transfused Allogeneic Blood Units (in Digits).
研究概览
简要总结
Sixty patients aged between 60 and 75 years old of both sex of ASA physical status I and II were included in this randomized study who were divided into the study group of 30 patients who had been transfused autologous blood and the control group of 30 patients who had been transfused only allogeneic blood. Parenteral iron preparation was given to all patients of the study group after each donation. Intraoperatively all patients of the study group received 2 grams of intravenous tranexamic acid. This study was conducted through the laboratory analysis of the hemoglobin and the hematocrit values during blood donation and for both groups in the pre-operative and the post-operative period and the assessment of the amount of transfused blood units in both groups.
详细描述
A total of 60 patients were included in this randomized study that were divided into a study group of 30 patients, who had been transfused autologous blood and a control group of 30 patients who had been transfused only allogeneic blood. Parenteral iron preparation was given to all patients of the study group after each donation. Intraoperatively all patients of the study group received 2 g of intravenous TXA.
This study was conducted through laboratory analysis of hemoglobin and hematocrit values during blood donation and for both groups in the preoperative and the postoperative period and the assessment of the amount of transfused blood units in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective revision total hip replacement surgery was performed in 60 patients aged between 60 and 75 years old of both sex of ASA physical status I and II of 70-90 kg body weight and height 160-180 cm.
排除标准
- •This study excluded cases of revision total hip arthroplasty (RTHA) for infection or fractures as well as early revisions for dislocations secondary to implant malposition. Preoperative autologous blood donation was not done in patients with cardiac decompensation, severe hemodynamic problems, respiratory insufficiency, severe defect of central nervous system, active infection, blood disease or coagulopathies.
研究组 & 干预措施
Control group (n=30)
The control group, which consisted of 30 patients who were transfused only allogeneic blood.
干预措施: transfused only allogeneic blood. (Other)
Preoperative blood donation (n=30)
the study group including 30patients who were transfused pre-operatively donated autologous blood, either during surgery or after it.
干预措施: transfused pre-operatively donated autologous blood. (Other)
Preoperative blood donation (n=30)
the study group including 30patients who were transfused pre-operatively donated autologous blood, either during surgery or after it.
干预措施: intravenous tranexamic acid (TXA) infusion (Drug)
结局指标
主要结局
Number of Transfused Allogeneic Blood Units (in Digits).
时间窗: 48-72 hours after surgery.
次要结局
- Our Secondary Outcome Measure Was to Assess the Post-operative Hospital Stay (Days).(48-72 hours after surgery.)
研究者
Dr.Ibrahim Mamdouh Esmat
MD, Lecturer of Anesthesia and Intensive Care Medicine, Ain Shams University Hospitals
Ain Shams University