Efficacy and Safety of Desmopressin Combined With Tranexamic Acid on the Blood Loss and Transfusion Need During and After Scoliosis Correction Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- blood loss
研究概览
简要总结
Intraoperative administration of tranexamic acid (TXA,T) reduces significantly blood loss and blood transfusion requirements during spinal posterior fusion in adolescents with scoliosis. TXA acts mainly by inhibit the plasminogen activator.
Desmopressin (DDAVP ,D) can inhibit the fibrinolytic activity by inducing the release of von Willebrand factor from the endothelial cells. But at the same time, it releases tissue-type plasminogen activator (t-PA), which may cripple its hemostatic effect.
The investigators supposed that if the investigators combine TXA with DDAVP in scoliosis correction surgery, the blood loss and the transfusion need would be reduced significantly.
详细描述
Intraoperative administration of tranexamic acid (TXA,T) reduces significantly blood loss and blood transfusion requirements during spinal posterior fusion in adolescents with scoliosis. TXA acts mainly by inhibit the plasminogen activator. Desmopressin (DDAVP ,D) can inhibit the fibrinolytic activity by inducing the release of von Willebrand factor from the endothelial cells. But at the same time, it releases tissue-type plasminogen activator (t-PA), which may cripple its hemostatic effect.
The investigators designed a a randomized double-blind clinical combining TXA with DDAVP in scoliosis correction surgery to observe if the blood loss and the transfusion need would be reduced or not.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •idiopathic scoliosis patients undergoing posterior scoliosis correction surgery
- •American society of anesthesiologists(ASA) classification:Ⅰ-Ⅱ
- •patients who agreed to participate in this study and has signed the informed consent
排除标准
- •blood disease，such as anaemia, idiopathic thrombocytopenic purpura(ITP)
- •history of bleeding or ecchymosis
- •disorders of laboratory examination on platelets(PLT),prothrombin time(PT),activated partial thromboplastin Time(aPTT),Fibrinogen,D-dimers
- •hypertension
- •cardiac disease,such as unstable angina, myocardial infarction in recent sis months, cardiac disfunction, congenital heart disease, pulmonary heart disease
- •cerebral ischemia
- •administering with anticoagulants or nonsteroidal anti-inflammatory drug(NSAID)
- •hepatic or renal disease or disfunction
- •blood transfusion in recent one month
研究组 & 干预措施
Group TN
Tranexamic acid and sodium chloride injection at 10mg/kg, IV (in the vein) for 30min, before incision.Then at 1mg/kg/h, IV pump, until the surgery is over.
Normal saline (NS) 100ml IV for 20min, before incision.
干预措施: tranexamic acid and sodium chloride injection (Drug)
Group TN
Tranexamic acid and sodium chloride injection at 10mg/kg, IV (in the vein) for 30min, before incision.Then at 1mg/kg/h, IV pump, until the surgery is over.
Normal saline (NS) 100ml IV for 20min, before incision.
干预措施: normal saline (Drug)
Group TD
Tranexamic acid and sodium chloride injection at 10mg/kg, IV (in the vein) for 30min,before incision.Then at 1mg/kg/h,IV pump,until the surgery is over.
Desmopressin acetate injection at 0.3μg/kg dissolved in 100ml NS, IV for 20min, before incision.
干预措施: tranexamic acid and sodium chloride injection (Drug)
Group TD
Tranexamic acid and sodium chloride injection at 10mg/kg, IV (in the vein) for 30min,before incision.Then at 1mg/kg/h,IV pump,until the surgery is over.
Desmopressin acetate injection at 0.3μg/kg dissolved in 100ml NS, IV for 20min, before incision.
干预措施: desmopressin acetate injection (Drug)
结局指标
主要结局
blood loss
时间窗: during and 3 days after the surgery
The blood loss include the volume of blood in suction bottles, the weight of sponges and seroma volume of drainage 3 days after surgery. All fluids added to the surgical field intraoperatively were carefully quantified and deducted from the measured blood loss.
次要结局
- blood transfusion(during and 3 days after the surgery)
研究者
Liu Weifeng
attending doctor
First Affiliated Hospital, Sun Yat-Sen University