The Effect of Topical and Intravenous Tranexamic Acid (TXA) on Thrombogenic Markers in Patients Undergoing Total Knee Replacement
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Levels of Plasmin Anti-plasmin (PAP) - Marker of Fibrinolysis
研究概览
简要总结
Tranexamic acid (TXA) is a drug that is being used more frequently at the Hospital for Special Surgery to lessen the amount of blood loss after total knee replacement (TKR). It is an anti-fibrinolytic agent, which means that it promotes the formation of blood clots. TXA can be given either intravenously or topically (placed directly on the open wound) before wound closure. Patients with certain medical conditions have been found to have a high risk of thrombosis after being given intravenous TXA, which may lead to serious complications. However, to date, no high-risk patients have been identified for use of topical TXA. This study will look at thrombogenic markers (proteins found in blood that promote clot formation) after TXA is given either intravenously or topically. If the effect on these markers is similar between intravenous and topical use of TXA, then the safety of topical TXA should be questioned. Of note, these markers have never been measured after TXA has been given topically. As a result, this information would be important for the medical community.
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)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing primary unilateral total knee replacement with a participating surgeon
- •Patients aged 18-80
排除标准
- •All patients on steroid therapy regardless of dose, duration, or treatment or those requiring stress-dose steroids preoperatively
- •Patients who will require postoperative use of Coumadin, Xarelto, or Plavix
- •Use of non-steroidal anti-inflammatory drugs (NSAIDs) within 1 week of surgery
- •Hypersensitivity to tranexamic acid
- •Renal dysfunction (Creatinine clearance < 40 ml/min)
- •Hepatic dysfunction (AST or ALT 2x upper limit of normal)
- •Cardiac exclusions: coronary stent, history of myocardial infarction, positive stress test, atrial fibrillation, advanced coronary artery disease
- •Advanced chronic obstructive pulmonary disease or advanced interstitial lung disease
- •History of venous thromboembolism
- •Hypercoagulability (e.g. antiphospholipid syndrome, genetic hypercoagulability with or without prior venous thromboembolism)
- •History of stroke or transient ischemic attack
研究组 & 干预措施
Intravenous tranexamic acid
Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released.
干预措施: Intravenous tranexamic acid (Drug)
Intravenous tranexamic acid
Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released.
干预措施: Topical saline (Drug)
Topical tranexamic acid
Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given.
干预措施: Topical tranexamic acid (Drug)
Topical tranexamic acid
Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given.
干预措施: Intravenous saline (Drug)
结局指标
主要结局
Levels of Plasmin Anti-plasmin (PAP) - Marker of Fibrinolysis
时间窗: 4 hours after tourniquet release
Levels of PAP will be measured in peripheral blood and wound drainage at 4 hours after tourniquet release.
次要结局
- Levels of Prothrombin Fragment 1.2 (PF1.2) - Marker of Thrombin Generation(before cementing, 1 hour after tourniquet release, 4 hours after tourniquet release)
- Levels of Tranexamic Acid(Intraoperative (before cementing), 1 hour after tourniquet release (TQR), 4 hours after tourniquet release(TQR))
- Calculated Postoperative Blood Loss(Duration of inpatient hospital stay (average of 3 days))
- Levels of Hemoglobin(1 hour after tourniquet release, POD 1, POD 2)
- Levels of Hematocrit(1 hour after tourniquet release, POD 1, POD 2)
- Constavac Blood Drainage(4 hours after tourniquet release)
- Incidence of Thrombosis (DVT/PE)(Postoperative day 14 (2 weeks after surgery))
- Patients Who Had 1 Unit of Blood Transfusion Administered(Duration of inpatient hospital stay (average of 3 days))
- Time to Physical Therapy Discharge(During Hospital Stay)
- Length of Hospital Stay(Length of Hospital Stay)
- Levels of IL-6 in Blood(Intraoperative, 1 hour post Tourniquet Release (TQR), 4 hour post Tourniquet Release (TQR))
- Levels of Plasmin Anti-plasmin (PAP) - Marker of Fibrinolysis(Intraoperative, 1 hour post Tourniquet Release (TQR))
- Levels of Prothrombin Fragment 1.2 (PF1.2) - Marker of Thrombin Generation in Wound Blood(Intraoperative, 4 hour post Tourniquet Release (TQR))