Impact of Tranexamic Acid Use on Blood Loss and Transfusion Rates After Hip Reconstruction in Children, A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- amount of intraoperative blood loss
研究概览
简要总结
Surgical hip reconstruction reduces the hip joint through soft tissue releases and osteotomies of the femur and/or pelvis. Blood loss and subsequent blood transfusion are normal consequences of hip reconstruction.
详细描述
the use of antifibrinolytics (AFs) to limit blood loss peri-operatively has been popularized in certain subspecialties. AFs have been studied extensively in adults undergoing various orthopedic procedures including spine and total joint arthroplasty, and have been proven to reduce blood loss and reduce the risk of blood transfusion. Similarly, AFs are used in pediatric patients undergoing cardiac surgery as well as craniofacial operations. Tranexamic acid (TXA) is a synthetic anti-fibrinolytic agent that works by reversibly blocking plasminogen and thereby promoting hemostasis through the prevention of fibrin degradation. Current literature investigating the safety and effectiveness of TXA in children undergoing orthopedic procedures is limited.
We hypothesize that patients treated with TXA will have reduced blood loss and transfusion requirements compared with those who did not receive TXA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I - II
- •Scheduled for acetabular osteotomy and/or proximal femoral derotation osteotomies.
排除标准
- •Patient's guardian refusal to participate in the study.
- •Children known to have pre-existing bleeding or coagulation disorders.
- •Children with anemia; defined according to (WHO ) cutoffs as Hb level<11g/dl for girls and <12g/dl for boys
- •History of epilepsy.
- •History of renal insufficiency or failure
研究组 & 干预措施
T group
each participant will receive 15 mg/kg of tranexamic acid diluted in a 10 mL syringe slowly over 10-15 minutes, 15 minutes before skin incision.
干预措施: Tranexamic acid (Drug)
TC group
each participant will receive 10 mg/kg of tranexamic acid diluted in a 5 mL syringe slowly over 5 minutes, 15 minutes before skin incision, and A caudal epidural block with 1 mL/kg of 0.25% bupivacaine.
干预措施: Tranexamic acid (Drug)
TC group
each participant will receive 10 mg/kg of tranexamic acid diluted in a 5 mL syringe slowly over 5 minutes, 15 minutes before skin incision, and A caudal epidural block with 1 mL/kg of 0.25% bupivacaine.
干预措施: caudal epidural block (Procedure)
C group
each participant will receive a caudal epidural block with 1 mL/kg of 0.25% bupivacaine.
干预措施: caudal epidural block (Procedure)
P group
participants will receive the regular standard care without adding tranexamic acid or caudal epidural block
干预措施: Placebo (Other)
结局指标
主要结局
amount of intraoperative blood loss
时间窗: 24 hours
calculated from the fall in red blood cell volume
次要结局
- Rate of blood transfusion(24 hours)
- length of hospital stay(24 hours)
- Incidence of adverse effects or complications of TXA(24 hours)
研究者
Shimaa Abbas Hassan
lectrure of Anesthesia
Assiut University