Does Early Administration of Tranexamic Acid Decrease Perioperative Blood Loss in Addition to Intraoperative Tranexamic Acid for Hip Fracture Patients?
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Postoperative Blood Transfusion
研究概览
简要总结
This is a prospective clinical study designed to assess blood loss in intracapsular and extracapsular hip fractures undergoing operative fixation at a Level II trauma center. It is well established in the orthopedic literature that tranexamic acid (TXA) decreases blood loss and need for postoperative blood transfusion in hip fracture patients as well as total joint arthroplasty patients. A typical dosing pattern, and the dosing pattern employed at our institution, is 1 gram IV infused prior to incision followed by 1 gram IV infused at the time of wound closure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 是
入选标准
- •All adult (18 years old or older) hip fracture patients presenting with an acute hip fracture and undergoing operative fixation
排除标准
- •Polytrauma patients
- •Previous operation on the ipsilateral hip
- •Patients with coagulopathies (Factor V Leiden, Sickle Cell Anemia, Etc.)
- •Patients with < 6-month history of thromboembolic event (DVT/PE), Stroke, Cardiac Stents, or Myocardial Infarction (MI)
- •History of seizure disorder
- •Patients on birth control
- •Pregnant Women
- •Active thromboembolic disease (DVT/PE, MI, Stroke)
研究组 & 干预措施
Early Adminstration of TXA + Intraoperative TXA
This group receives 1 G of TXA as soon as possible after a diagnosis of an acute hip fracture if the patient meets inclusion and exclusion criteria. The group will also receive 2 grams of TXA total intraoperatively.
干预措施: Tranexamic acid (Drug)
Intraoperative only TXA
This group will only receive the intraoperative TXA.
干预措施: Tranexamic acid (Drug)
结局指标
主要结局
Postoperative Blood Transfusion
时间窗: Up to two weeks
Patient receives a blood transfusion during their postoperative stay in the hospital
Overall Blood Loss
时间窗: Up to two weeks
Calculate the difference in postoperative blood loss between groups
次要结局
- Length of hospital stay(Up to two weeks)
- Postoperative Pain(Up to two weeks)
- Wound complications(Up to two weeks)
- Acute DVT/PE(Up to two weeks)
研究者
Jacob Hinkley
Resident Physician
Ascension Health