Effectiveness of Preoperative Intravenous Tranexemic Acid on Reduction of Perioperative Blood Loss in Open Intramedullary Nail Fixation of Femoral Shaft Fractures in Mulago
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Change in Hemoglobin Concentration from Preoperative to 72 Hours Postoperative
研究概览
简要总结
This clinical study aims to evaluate the safety and effectiveness of administering a single intravenous dose of tranexamic acid (TXA) before surgery to reduce blood loss in patients undergoing open intramedullary nailing for femoral shaft fractures. In many resource-limited settings, including Uganda, this surgical approach is common due to lack of fluoroscopic equipment, and it is known to be associated with significant perioperative blood loss.
Tranexamic acid is an antifibrinolytic agent that helps stabilize blood clots and is widely used to reduce bleeding in major surgeries such as joint replacements and spinal procedures. However, its role in trauma-related open femoral surgeries in low-resource settings remains underexplored.
This study investigates whether preoperative intravenous TXA can safely reduce blood loss and transfusion needs during and after surgery in patients with isolated femoral shaft fractures managed at Mulago National Referral Hospital.
详细描述
This is a prospective, open-label, single-arm cohort study designed to assess the safety and effectiveness of preoperative intravenous tranexamic acid (TXA) in adult patients undergoing open intramedullary nailing for femoral shaft fractures in a resource-limited hospital setting.
The study enrolled 43 adult participants with isolated, closed femoral shaft fractures scheduled for surgical fixation at Mulago National Referral Hospital. Each participant received a single dose of intravenous tranexamic acid (15 mg/kg), administered over 10 minutes approximately 10 minutes prior to skin incision. The dose was prepared and delivered by the anesthetist in the operating theatre.
The primary objective of the study is to estimate perioperative blood loss, assessed by comparing preoperative hemoglobin concentration (taken 2 hours before surgery) to postoperative hemoglobin (taken 72 hours after surgery). Secondary objectives include assessing the proportion of patients requiring blood transfusions and documenting any adverse events associated with TXA administration, such as hypotension, nausea, or allergic reactions.
Surgical procedures were performed using either antegrade or retrograde open intramedullary nailing techniques. Standard perioperative care was provided, including preoperative antibiotics and either spinal or general anesthesia. All blood draws were conducted under aseptic conditions. Transfusion decisions followed standard clinical protocols based on clinical signs and hemoglobin thresholds.
This study is intended to inform clinical practice in low-resource settings by providing data on the potential utility of tranexamic acid in orthopedic trauma surgery where blood conservation is especially critical.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years and above
- •Patients with isolated, closed femoral shaft fractures
- •Scheduled for open intramedullary nail fixation at Mulago National Referral Hospital
- •Able and willing to provide written informed consent
排除标准
- •Injury duration of more than one month
- •Patients undergoing repeat surgery for a femoral fracture
- •Pathological fractures of the femur
- •Patients undergoing ORIF for more than one fracture during the perioperative period
- •Known allergy to tranexamic acid
- •History of bleeding disorders
- •Presence of significant medical comorbidities (e.g., diabetes mellitus, history of deep vein thrombosis, or pulmonary embolism)
- •Current use of anticoagulant medications
研究组 & 干预措施
Single Arm: IV TXA Before Femoral Nailing
Participants in this arm received a single preoperative intravenous dose of tranexamic acid (Kapron®, Amoun Pharma, Egypt) at 15 mg/kg, administered slowly over 10 minutes approximately 10 minutes before skin incision. The intervention was intended to reduce perioperative blood loss in patients undergoing open intramedullary nail fixation of isolated femoral shaft fractures at Mulago National Referral Hospital, Uganda. All participants received standard perioperative care, including preoperative antibiotics and anesthesia. No control or placebo group was included in this single-arm, open-label study.
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Change in Hemoglobin Concentration from Preoperative to 72 Hours Postoperative
时间窗: From 2 hours before surgery to 72 hours after surgery
Hemoglobin concentration (g/dL) was measured 2 hours before surgery and again 72 hours after surgery. The difference between these two values was used to estimate total perioperative blood loss.
次要结局
- Proportion of Patients Requiring Perioperative Blood Transfusion(From 2 hours before surgery to 72 hours after surgery)
- Incidence and Profile of Adverse Events Following Tranexamic Acid Administration(From 2 hours before surgery to 72 hours after surgery)
研究者
Kabazzi Kaweesa Paul
Principle Investigator
Masaka Regional Referral Hospital