The Impact of Additional Post-operative Doses of Tranexamic Acid on Pain, Mobility and Bleeding Following Total Hip and Total Knee Arthroplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Step counts at 24 and 48 hours post -operative
研究概览
简要总结
Tranexamic acid (TXA) is an anti-fibrinolytic agent developed in the 1960s that has been safely used to reduce blood loss, transfusion rates and bleeding-associated mortality in trauma, obstetrics and orthopedic surgery, including hip fracture care and arthroplasty.
The efficacy and safety profile of TXA has been extensively studied in numerous clinical trials and observational studies. Its wide range of applications, combined with its favourable risk-benefit ratio, has led to the incorporation of TXA into clinical guidelines and protocols worldwide.
This RCT aims to compare the current standard dosing for TXA to additional TXA doses given orally post-operatively for THA and TKA patients. The goal is to compare the following between study groups: visible bleeding on post-operative dressing, mobilization (steps, amount of time moving around), pain (visual analog scale), function (Oxford hip and knee scales) and ROM at four to six weeks.
详细描述
Total knee arthroplasty (TKA) and total hip arthroplasty (THA) are some of the most common surgical procedures performed in elderly patients, with the main indication being end-stage osteoarthritis. While these procedures can result in a significant amount of bleeding, pain and stiffness post-operatively, they have been increasingly performed as day surgeries and with reduced length of stay.
Tranexamic acid (TXA) is an anti-fibrinolytic agent developed in the 1960s that has been safely used to reduce blood loss, transfusion rates and bleeding-associated mortality in trauma, obstetrics and orthopedic surgery, including hip fracture care and arthroplasty.
The efficacy and safety profile of TXA has been extensively studied in numerous clinical trials and observational studies. Its wide range of applications, combined with its favourable risk-benefit ratio, has led to the incorporation of TXA into clinical guidelines and protocols worldwide.
The current standard of care at St-Mary's for TXA use is one gram given intravenously (IV) at the beginning of the replacement and one gram given during cementation. However, despite the established benefits of TXA, the optimal dosing regimen continues to be an area of ongoing research and discussion.
TXA and post-operative hemoglobin and hematocrit levels The use of TXA in knee and hip arthroplasty has been shown to have clear and significant benefits in reducing the post-operative drop in hemoglobin (Hb) and hematocrit (Hct) but the duration of use has ranged from a single pre-operative dose to a prolonged 14-day course. Researchers reported higher post-operative Hb and Hct following THA and TKA using a three-day course of TXA compared to a single pre-operative dose of 1.5g. However another study, showed no added benefit of the addition of a second post-operative dose to the single pre-operative dose. Similarly, an randomized controlled trial (RCT) comparing TXA doses at pre, during and three hours post-operative to the same with additional doses at six and 12 hours and showed no added benefit of the additional two doses on Hb or Hct levels. In contrast to this, three RCTs performed in 2019 and 2021 showed improved Hb and Hct levels with TXA use beyond a minimum of seven hours post-operatively and two involved the use of TXA given by mouth (PO), which is ideal in the ambulatory setting.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Patients will be recruited in the pre-operative clinic for surgery and randomized once all paperwork is completed. This randomization will be completed by a research assistant and transmitted to pharmacy to allow for the delivery of the proper medication packet. Neither the patient nor the treating physician will be made aware of the group to which the patient has been assigned.
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 adults undergoing primary TKA and THA at St-Mary's Hospital
排除标准
- •Age < 18 years
- •Known hypersensitivity or allergy to TXA
- •Previous history of thromboembolic disease
- •Active malignancy (all current cancers other than local skin cancer)
- •Significant renal disease (hematuria, dialysis, kidney transplant)
- •History of convulsions
- •Known defective colour vision
- •Inability or unwillingness to use MyMobility app
- •Unable to communicate in French or English
研究组 & 干预措施
1)Standard care: 1G TXA IV
1 gm TA IV given prior to incision and 1G TXA IV during cementation or closure
干预措施: Tranexamic acid (Drug)
2) Standard + 1G oral TXA - 0 and 8 hours post-operatively
Standard + 1G oral TXA given at 0 and 8 hours post-operatively
干预措施: Tranexamic acid (Drug)
3) Standard + 1G oral TXA given at 0, 8, 16 and 24 hours post-operatively
Standard + 1G oral TXA given at 0, 8, 16 and 24 hours post-operatively
干预措施: Tranexamic acid (Drug)
结局指标
主要结局
Step counts at 24 and 48 hours post -operative
时间窗: Post-operative
We hypothesize that patients receiving additional doses of TXA will mobilize more at 24 and 48 hours post- operatively and that this will be dose-dependent.
次要结局
- Patient self-assessment of functionality and pain measured pre-operatively, 4 to 6 weeks postoperatively, 3 months postoperatively and 6 months post-operatively following total hip arthroplasty utilizing the Oxford Hip Score (OHS):(4 to 6 weeks postoperatively, 3 months postoperatively and 6 months post-operatively)
- Patient self-assessment of functionality and pain measured pre-operatively, 4 to 6 weeks postoperatively, 3 months postoperatively and 6 months post-operatively following total knee arthroplasty utilizing the Oxford Knee Score (OKS):(4 to 6 weeks postoperatively, 3 months postoperatively and 6 months post-operatively)
- Bleeding Complications requiring intervention(Return to the emergency room or bleeding complications will be noted.)
- Daily step counts(Post-operative day 0,1,2,3,5,7 and 4 to 6 weeks postoperatively.)
- Range of motion (ROM) of the hip (if applicable):(4 - 6 weeks post op)
- Range of motion (ROM) of the knee (if applicable):(4 - 6 weeks post op)
- Measure of quality of life using the 12-Item Short Form Survey (SF-12):(This measurement will be taken pre-operatively, 4 to 6 weeks postoperatively, 3 months postoperatively and 6 months post-operatively.)
- Assessment and screening for depression and anxiety in patients utilizing the Hospital Anxiety Depression Scale (HADS) :(Pre-operative)
- Reported pain self-reported in patient journal and possibly in-patient charts:(These journals and/or in-patient charts will be verified on postoperative day 0,1,2,3,5 and 7.)
- Assessment of catastrophic thinking related to pain utilizing the Pain Catastrophizing Scale (PCS):(Pre-operative)
- Reported pain using the visual analog pain (VAS) scale:(This measurement will be collected on postoperative day 0, 1,2,3,5 and 7.)
研究者
Anthony Albers, MD
Director of Orthopaedic Research, Orthopaedic Surgeon
St. Mary's Research Center, Canada