A Randomised Controlled Trial of Intra-Operative Cell Salvage During Caesarean Section in Women Needing Blood Transfusion
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 120
- 主要终点
- blood loss of the subjects in 5 days of after operation
研究概览
简要总结
The purposes of this study are:
- To compare the difference of blood loss of the patients undergoing cesarean section between intraoperative blood recovery and allogeneic blood transfusion.
- To compare the safety of the two methods.
- To evaluate the medical cost and the overall cost of the two methods.
详细描述
Preoperative: 1.To select patients according to the criteria.2.To obtain the consent of the obstetrician, the anesthesiologist, and the patients.
Intraoperative:According to local blood transfusion guidelines, obstetric advice, anesthesia advice(tentative: before a blood transfusion maternal's Hb less than 70g/L or Hb:70-100g/l before a blood transfusion according to the blood transfusion program and doctor's determine to do the blood transfusion),those who need blood transfusion during cesarean section will be randomly assigned to the following two groups:
- cesarean section using intraoperative blood recovery group (test group).
- cesarean section using allogeneic blood transfusion group (control group).
The theoretical amount of blood transfusion should be based on the following formula:
The amount of blood transfusion needed (ML) * Hb= (Hb2-Hb1) * blood volume of blood transfusion Hb1: actual measured hemoglobin; Hb2: target hemoglobin (100 g / L) Blood volume = 100ml/kg * body weight The difference between the actual blood transfusion and the theoretical blood transfusion should be controlled within ± 15% of the theoretical blood transfusion (in terms of hemoglobin), whether the test group or the control group.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Delivery by elective or emergency caesarean section with an identifiable increased risk of haemorrhage.
- •Ability to provide informed consent
- •Participants need blood transfusion
排除标准
- •Hb<70g/L before operation
- •Participants have a history of blood transfusion
- •Blood type is RH blood type
- •Sickle cell disease
- •The obstetricians and anesthesia doctors think some cases existing intraoperatie blood recycling contraindications
- •PT and APTT is 1.5 times longer than normal and above, or platelet is less than 50 * 109 / L preoperative
- •Cultural or social beliefs contraindicating blood transfusion.
- •Significant antibodies making it difficult to find cross matched blood for transfusion
- •participation in another clinical trial within 3 months prior to selection
- •ability to provide informed consent
研究组 & 干预措施
group intra-operative cell salvage
The theoretical amount of blood transfusion should be based on the following formula:
The amount of blood transfusion needed (ML) * Hb= (Hb2-Hb1) * blood volume of blood transfusion Hb1: actual measured hemoglobin; Hb2: target hemoglobin (100 g / L) Blood volume = 100ml/kg * body weight The difference between the actual blood transfusion and the theoretical blood transfusion should be controlled within ± 15% of the theoretical blood transfusion (in terms of hemoglobin), whether the experimental group or the no intervention group.
干预措施: intra-operative cell salvage (Combination Product)
group intra-operative cell salvage
The theoretical amount of blood transfusion should be based on the following formula:
The amount of blood transfusion needed (ML) * Hb= (Hb2-Hb1) * blood volume of blood transfusion Hb1: actual measured hemoglobin; Hb2: target hemoglobin (100 g / L) Blood volume = 100ml/kg * body weight The difference between the actual blood transfusion and the theoretical blood transfusion should be controlled within ± 15% of the theoretical blood transfusion (in terms of hemoglobin), whether the experimental group or the no intervention group.
干预措施: allogeneic blood transfusion (Combination Product)
group allogeneic blood transfusion
The theoretical amount of blood transfusion should be based on the following formula:
The amount of blood transfusion needed (ML) * Hb= (Hb2-Hb1) * blood volume of blood transfusion Hb1: actual measured hemoglobin; Hb2: target hemoglobin (100 g / L) Blood volume = 100ml/kg * body weight The difference between the actual blood transfusion and the theoretical blood transfusion should be controlled within ± 15% of the theoretical blood transfusion (in terms of hemoglobin), whether group intra-operative cell salvage or group allogeneic blood transfusion.
干预措施: allogeneic blood transfusion (Combination Product)
结局指标
主要结局
blood loss of the subjects in 5 days of after operation
时间窗: in fifth day post operation
calculate the changes of Hct and the amount of blood transfusion
次要结局
- postoperative APTT in the fifth day post operation(in the fifth day post operation)
- postoperative Hb in first day post operation(in first day post operation)
- postoperative APTT in first day post operation(in first day post operation)
- postoperative PT in the fifth day post operation(in the fifth day post operation)
- postoperative Hct in first day post operation(in first day post operation)
- postoperative PT in first day post operation(in first day post operation)
- postoperative Hct in the fifth day post operation(in the fifth day post operation)
- postoperative Hb in the fifth day post operation(in the fifth day post operation)
- Total intraoperative and postoperative blood transfusion(from the date of operation until the date of hospital discharge, assessed up to 7 days)
- Length of hospital stay(from the date of operation until the date of hospital discharge, assessed up to 7 days)
- first mobilization(from the date of operation up to first mobilization, assessed up to 7 days)
研究者
Ting Li
associate chief physician
Wenzhou Medical University