Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement in Low Energy Hip Fracture Patients?
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Number of Subjects Transfused at Least 1 Unit of Packed Red Blood Cells
研究概览
简要总结
Intertrochanteric hip fractures typically result in blood loss from the fracture and require surgery that can cause further blood loss. This study is being done to look at a medication called tranexamic acid which may reduce blood loss and the need for blood transfusions associated with surgery.
详细描述
The use of TXA in orthopedic trauma patients is an area of current research interest. A 2010 prospective randomized, controlled trial of perioperative TXA demonstrated reduction in transfusion requirements for intertrochanteric hip fractures treated with short, cephalomedullary nails. This was clinically, though not statistically, significant. Investigators recently conducted a randomized, controlled trial at this institution to evaluated the use of TXA in patients with femoral neck fractures treated with hemiarthroplasty or total hip arthroplasty and found clinically, albeit not statistically, significant reduction in transfusion requirement (accepted for publication). Perhaps tempering the effect seen with perioperative administration of TXA is the blood loss that occurs prior to surgery, the so-called "hidden" blood loss that can be as substantial as 1/3 of total blood loss from a hip fracture. This raises the question whether administration of tranexamic acid at the time of initial presentation after fracture could improve the perioperative care of these patients by decreasing the proportion of patients requiring transfusion and decreasing total blood loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Using dynamic allocation will ensure that the study subjects will remain balanced on the stratification factors and the treatment group assignment throughout the entire subject accrual phase. This system will be utilized by Central pharmacy personnel to generate the treatment group assignments. Medications will then be delivered from the Central Pharmacy to the emergency department in packaging that does not delineate whether it contains placebo or tranexamic acid. Thus, the patient, treating surgeon, emergency department physician, residents, hospitalist group, anesthesiologist, and data collectors will remain blinded to the treatment assignment.
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
- •AO/OTA fracture classification 31A
- •Surgically treated with sliding hip screw or cephalomedullary nail (short or long)
- •Low energy, isolated injury
排除标准
- •Intracapsular hip fractures: AO/OTA fracture classification 31B-C
- •Polytrauma patients
- •Creatinine clearance less than 30 mL/min
- •History of unprovoked VTE and/or recurrent VTE
- •Known history of Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant
- •Pregnancy or breastfeeding (pregnancy tests will be performed on all patients of child-bearing potential)
- •History of CVA, MI, or VTE within the previous 30 days
- •Coronary stent placement within the previous 6 months
- •Disseminated intravascular coagulation
- •Intracranial hemorrhage
研究组 & 干预措施
Tranexamic Acid Arm (TXA)
Subjects will be treated with early administration of TXA in the Emergency Department
干预措施: Tranexamic Acid (TXA) (Drug)
Control Arm
Subjects will be treated with a placebo in the Emergency Department
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Subjects Transfused at Least 1 Unit of Packed Red Blood Cells
时间窗: Length of hospitalization (approximately 3 to 5 days)
Transfusion will be considered for all patients with hemoglobin values of less than 8 g/dL with persistent symptoms or history of significant cardiac disease that may render the patient less able to compensate for significant anemia. Blood transfusion will be considered in all patients with hemoglobin less than 7 g/dL, regardless of symptoms.
次要结局
- (Myocardial Infarction) MI Diagnosed(Within 6 months of surgery)
- Number of Subjects to Experience Symptomatic Venous Thromboembolism (VTE)(Within 6 months of surgery)
- Cerebrovascular Accident (CVA) Diagnosed(Within 6 months of surgery)
- All-cause Mortality(At 6 months after surgery)
- Number of Units of Packed Red Blood Cells Transfused(Length of hospitalization (approximately 3 to 5 days))
- Calculated Blood Loss(Length of hospitalization (approximately 3 to 5 days))
- Wound Complications(Within 6 months of surgery)
研究者
Brandon James Yuan
Principal Investigator
Mayo Clinic