Effect of Thromboelastography® Guided versus Conventional Haemostatic Therapy on Intraoperative Antifibrinolytic and Transfusion requirement in Elective complex spine surgeries- A Randomized, Parallel Arm study.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Total dose of tranexamic acid- mg per kg
研究概览
简要总结
· This randomized parallel arm study (1:1 allocation, total sample size 172) will be done in the Orthopedic/ Neurosurgery Modular operation theatre complex and wards at All India Institute of Medical Sciences Bhopal. After ethical committee approval and clinical trial registration, participants will be recruited as per the specified inclusion and exclusion criteria. Stratified block randomization with varying block size according to surgical extent (less than or more than 4 segments will be done into either Thromboelastography guided (T) or Conventional (C) intraoperative haemostatic treatment groups, with 86 participants each, with the use of an opaque serially numbered sealed envelope technique for allocation concealment. Baseline Thromboelastography will be done on all study participants. The transfusion trigger will be 8gm/dl during surgery. Standard anesthetic and fluid management will be done during surgery. Intraoperative management will be as follows:
TEG Guided Treatment (Group T)- Thromboelastography two hourly or earlier to assess coagulation hemostasis. Tranexamic acid dose and blood product transfusion will be based on the percentage of clot lysis (Ly 30) and other TEG parameters.
Conventional Hemostatic therapy (Group (C) - Standard 15 mg/kg dose of Tranexamic acid after anesthetic induction. Hemostatic practices will be based on the routine strategy based on signs of bleeding, the patient’s hemodynamic status, and clinical judgment.
Follow-up: A blinded study investigator will assess the total dose of Tranexamic acid during surgery, transfusion of blood products on day of surgery and till 71 week after surgeryt. Follow up will be done daily in the first postoperative week for venous thromboembolism (VTE) using the Wells score and findings of hypercoagulability on TEG on the first, third, fifth, and seventh postoperative days.
• Expected outcome-
TEG-based hemostatic therapy will generate evidence for the optimal dose of Tranexamic acid required in elective complex spine surgery and may prevent unnecessary transfusion and postoperative VTE in the first seven postoperative days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adolescent and adult patients American Society of Anesthesiologists (ASA) Physical status I-III classification BMI less than 35Kg per msquare Undergoing instrumented spine surgery of thoracic or lumbar spine (between T1 and S1) by a posterior midline approach Providing informed consent to participate in the surgery.
排除标准
- •History of allergy or hypersensitivity to Tranexamic acid.
- •History of frequent bleeding, past or family history of thromboembolism (stroke, Non-fatal myocardial infarction, pulmonary embolism, bowel infarction) Current treatment with anticoagulants other than aspirin Laboratory values of Hemoglobin less than 10gm/dl, Serum creatinine more than 1.5 mg per dl, Platelet count less than 1.5 lakhs per cumm, International Normalized Ratio (INR) more than1.4, activated partial thromboplastin time more than 38 s.
- •Patients with a neoplastic, infectious spinal condition or polytrauma.
- •Minimally invasive spine surgery like endoscopic discectomy.
结局指标
主要结局
Total dose of tranexamic acid- mg per kg
时间窗: During surgery
Weighted average Tranexamic acid given per kg per hour during surgery.
时间窗: During surgery
次要结局
- Total number and type of blood products transfused in intervention versus comparator group(first 24 hours, first week of surgery)
- Incidence of hypercoagulability assessed by TEG parameters, IncidencE OF Thromboembolic events and average Wells score for Deep venous thrombosis and Pulmonary Embolism(First week after surgery)
研究者
Sunaina Tejpal Karna
AIIMS Bhopal