CTRI/2025/03/082166尚未招募4 期
Comparison of the effect of tranexamic acid- high verses standard dose upon intraoperative and postoperative blood loss in patients undergoing open Spine surgery -A Double blinded randomized control trial.
AIIMS Patna1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2025年3月17日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- 1.Blood loss intraoperatively
研究概览
简要总结
Primary purpose of the study is to compare the efficacy of high-dose (50mg/kg body wt. followed with 5mg/kg/hr for 5 hours) versus standard-dose(10mg/kg body wt. followed with 1mg/kg/hr for 5 hours) Tranexamic Acid in reducing blood loss during single and double-level open spine.Also to assess secondary outcomes like blood transfusion rates, surgical complications, length of hospital stay, and cost-effectiveness. Research hypothesis is High dose use of Tranaxamic acid is better than the standard dose used in single and double level spine surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Skeletally mature patients with preop hemoglobin more than 10 mg/dl with vertebral fractures, degenerative disc diseases, spondylodiscitis who needs open spine surgery.
- •2.People with normal levels of PT with INR and Aptt levels.
排除标准
- •1.Elevated PT, PTT, INR for any reason 2.Patients with cervical disc disease and cervical vertebral fracture who needs anterior cervical diskectomy and fusion.
- •3.Patients who need single level lumbar diskectomy, single level spine decompression for lumbar canal stenosis.
- •4.Patients with pathological fractures, intradural tumor and spine deformity 5.History of thrombotic events such as CVA and MI 6.History of bleeding disorder 7.History of traumatic brain injury and CPR 8.Cancer, or any other serious illness that affects treatment evaluation 9.Renal failure with GFR lower than 60 ml/min 10.Use of anticoagulants such as aspirin and dipyridamole 11.OCP consumption, pregnancy, or lactation 12.Revision spine surgery 13.Patient with intraoperative Dural tears.
结局指标
主要结局
1.Blood loss intraoperatively
时间窗: 1.Intraoperatively | 2.Postoperatively
2.Blood loss postoperatively
时间窗: 1.Intraoperatively | 2.Postoperatively
次要结局
- 1.The complications associated with the use of Tranexamic acid in spine surgery.
研究者
Aditya Kumar
AIIMS PATNA
研究点 (1)
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