EFFECT OF TRANEXAMIC ACID ON PERIOPERATIVE BLOOD LOSS IN REAMED INTRAMEDULLARY NAILING OF DIAPHYSEAL FEMORAL AND TIBIAL FRACTURES: A PROSPECTIVE COMPARATIVE STUDY
Effect of Tranexamic Acid on Perioperative Blood Loss in Reamed Intramedullary Nailing of Diaphyseal Femoral and Tibial Fractures: A Prospective Comparative Study.
Perioperative blood loss is one of the most frequently encountered and significant complications of spine surgery. Intraoperative and post-operative bleeding cause various complications and negatively affect patient outcomes. There are a range of methods that can be employed to both reduce the risk of bleeding and achieve hemostasis, one of which is the adjunct use of hemostatic agents. Intravenous administration of transxamic acid appears to reduce perioperative damage and the need for blood transfusions in spine surgery. The study is done in patients admitted to Dhulikhel Hospital undergoing elective open spine surgery, to study the efficacy of tranexamic acid in reducing blood loss and need of blood transfusion in patients undergoing spine surgery. Patients undergoing spine surgeries are enrolled and allocated by computer generated randomization into 2 groups, (a) placebo group, receiving 0.9% NaCl, (b) tranexamic acid group, receiving 2 doses of tranexamic acid(15mg/kg). Intraoperative and post-operative blood loss are measured. Study parameters include estimated blood loss, hemoglobin, hematocrit and number of blood transfusions required in post-operative setting. Study parameters are compared across two groups using appropriate statistical tools. This study will help us determine the role of tranexamic acid in reducing perioperative blood loss and need for blood transfusion in patients undergoing spine surgery.
HYPOTHESES OF THE STUDY:
Null hypothesis (H0): There is no significant effect of tranexamic acid in reduction of blood loss compared to study group Alternate hypothesis (H1): There is significant improved effect of tranexamic acid in reduction of blood loss.
Hence, H0 : Mean of Parameters of Control groups >= mean of parameters of Study groups.
H1: Mean of parameters of Control groups < Mean of parameters of Study groups
研究概览
地位
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Bagmati
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Dhulikhel、Bagmati、尼泊尔、45200
- Dhulikhel Hospital, Kathmandu University Hospital
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Patients aged 16-60 years
- Patients with isolated diaphyseal fracture (Shaft fracture of femur or Shaft fracture of tibia)
- Patients planned for reamed intramedullary nailing
- Patients willing to provide informed consent
Exclusion Criteria:
- Patients with polytrauma
- Fractures requiring open reduction
- Gustilo-Anderson Grade III open fractures
- Known history of coagulopathy
- International Normalized Ratio (INR) > 1.2
- Current use of anticoagulant therapy
- Current use of antiplatelet therapy
- Presence of major hepatic failure
- Presence of major renal failure
- Patients unwilling or unable to provide informed consent
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Tranexamic Acid Group
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In Tranexamic acid (TXA) group, single intravenous dose of Tranexamic Acid (15mg/kg) diluted in 50 ml of normal saline is administered 30 minutes prior to the induction of anesthesia.
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安慰剂比较:Placebo/ Standard Care group
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This group receives 50ml of normal saline and is labeled as standard care group.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Intraoperative Blood Loss Measured in Milliliters (mL)
大体时间:2 years
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Intraoperative blood loss during spine surgery will be measured in milliliters (mL) using suction drain collection and surgical sponge estimation.
Lower blood loss indicates better efficacy of tranexamic acid in reducing surgical bleeding.
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2 years
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Postoperative Blood Loss Measured in Milliliters (mL)
大体时间:2 years
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Postoperative blood loss will be assessed in milliliters (mL) from surgical drain output collected during the first 24 hours following surgery.
Lower postoperative blood loss indicates better efficacy of tranexamic acid.
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2 years
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Change in Hemoglobin Level Measured in Grams per Deciliter (g/dL)
大体时间:2 years
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Reduction in hemoglobin level will be assessed by comparing preoperative and postoperative hemoglobin values measured in grams per deciliter (g/dL).
Smaller reduction in hemoglobin indicates lower perioperative blood loss.
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2 years
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Intraoperative Blood Transfusion Requirement
大体时间:2 years
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Blood transfusion requirement during surgery will be measured as the number of blood units transfused intraoperatively.
Lower transfusion requirement indicates better blood conservation.
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2 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Adverse Effects Related to Tranexamic Acid
大体时间:2 years
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Adverse events related to tranexamic acid administration, including thromboembolic events, allergic reactions, or other drug-related complications, will be recorded during hospital stay and follow-up.
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2 years
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合作者和调查者
出版物和有用的链接
一般刊物
- Gausden EB, Qudsi R, Boone MD, O'Gara B, Ruzbarsky JJ, Lorich DG. Tranexamic Acid in Orthopaedic Trauma Surgery: A Meta-Analysis. J Orthop Trauma. 2017 Oct;31(10):513-519. doi: 10.1097/BOT.0000000000000913.
- Boucher M, Tremblay J, Pelet T, Dartus J, Belzile EL, Pelet S. Topical Versus Systemic Tranexamic Acid to Reduce Blood Loss After Total Knee and Total Hip Arthroplasty: A Systematic Review and Meta-Analysis. J Bone Joint Surg Am. 2025 Oct 15;107(20):2300-2309. doi: 10.2106/JBJS.24.01511. Epub 2025 Aug 5.
- Reale D, Andriolo L, Gursoy S, Bozkurt M, Filardo G, Zaffagnini S. Complications of Tranexamic Acid in Orthopedic Lower Limb Surgery: A Meta-Analysis of Randomized Controlled Trials. Biomed Res Int. 2021 Jan 16;2021:6961540. doi: 10.1155/2021/6961540. eCollection 2021.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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