Intravenous Tranexamic Acid to Reduce Blood Loss in Reverse Total Shoulder Arthroplasty
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Total Blood Loss
研究概览
简要总结
To the Investigators' knowledge, TXA has not been studied in the setting of reverse total shoulder arthroplasty. We propose a double-blinded, randomized, controlled trial comparing perioperative administration of TXA to placebo in the setting of RTSA. The purpose of this study is to examine the efficacy of TXA in reducing overall blood loss and transfusion rates in patients undergoing reverse total shoulder arthroplasty.
详细描述
Shoulder arthroplasty is a procedure used to relieve pain and dysfunction associated with arthritic destruction of the gleno-humeral joint. It has been demonstrated that in patients with concomitant rotator cuff deficiency, reverse total shoulder arthroplasty (rTSA) is an efficacious procedure that relieves pain as well as increases the lever-arm of the deltoid muscle, thus improving post-operative strength and range of motion.
However, perioperative blood loss in total shoulder arthroplasty can be significant, with an overall rate of allogeneic blood transfusion reported to be 7.4%-43% [1-5]. Patients undergoing reverse total shoulder arthroplasty are at even further risk of requiring a postoperative blood transfusion [2]. Blood transfusions are associated with significant risks to patient health that range from mild to life threatening.
Tranexamic acid (TXA) is an antifibrinolytic medication (reduces the destruction of blood clots, thus promoting the ability to stop bleeding) that is frequently used to reduce perioperative blood loss, blood transfusions and associated costs in major cardiac, vascular, obstetric, and orthopedic procedures. Currently, TXA is increasingly used in orthopedic joint reconstructive surgery and has proven to be safe and effective in reducing blood loss following total knee arthroplasty (TKA) and total hip arthroplasty (THA) [11-33]. Multiple recent meta-analyses have found that use of TXA in the setting of TKA and THA leads to significantly less overall blood loss and lower rates of blood transfusion without increasing rates of venous thromboembolism (VTE) or other complications [34-37]. TXA is now on formulary at William Beaumont Hospital.
100 patients slated to undergo elective reverse total shoulder arthroplasty will be recruited and randomized to receive either an infusion of the standard dose of TXA (10mg/kg) or placebo (an equivalent volume of normal saline) within 60 minutes prior to surgery and at wound closure.
Adult subjects 18 years of age or older will participate in this study after the objectives, methods, and potential hazards of the study have been fully explained, and after they have signed the informed consent form. The Investigator or designee is responsible for keeping a record of all subjects who sign an informed consent form for entry into this study
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing scheduled primary reverse total shoulder arthroplasty performed by J. Michael Wiater, MD.
- •Patients age 18 and older
排除标准
- •Pregnant* or breast-feeding women
- •Allergy to tranexamic acid
- •Acquired disturbances of color vision
- •Use of estrogen containing medications (i.e. oral contraceptive pills)
- •Hormone replacement therapy
- •Preoperative anemia [Hemoglobin (Hb) < 11g/dL in females, Hb < 12 g/dL in males]
- •Refusal of blood products
- •Preoperative use of anticoagulant therapy within 5 days prior to surgery
- •Low molecular weight heparin
- •Factor Xa inhibitors
- •Thrombin inhibitors
- •Coagulopathy
- •Thrombophilia
- •Antithrombin deficiency
- •Factor V Leiden
- •Antiphospholipid Syndrome
- •Protein C and S deficiency
- •History of heparin induced thrombocytopenia
- •Sickle cell anemia
- •Myeloproliferative disorders
- •Platelet < 150,00 mm3
- •International Normalized Ratio (INR) > 1.4
- •Partial Thromboplastin Time (PTT) > 1.4 times normal
- •A history of arterial or venous thromboembolism
- •Cerebral Vascular Accident
- •Deep Vein Thrombosis
- •Pulmonary Embolism
- •Subarachnoid hemorrhage
- •Active intravascular clotting
- •Major comorbidities
- •Coronary artery disease (New York Heart Association Class III or IV)
- •Previous MI
- •Severe pulmonary disease (FEV <50% normal)
- •Plasma creatinine > 115 μmol/L in males, > 100 μmol/L in females, or hepatic failure)
- •Participation in another clinical trial
- •*All women of child bearing potential must have a negative serum or urine pregnancy test.
研究组 & 干预措施
Tranexamic acid
Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.
干预措施: Tranexamic Acid (Drug)
Normal Saline
Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.
干预措施: Placebo (Drug)
结局指标
主要结局
Total Blood Loss
时间窗: Preoperative through Postoperative Days 1 and 2
Total Blood Loss as calculated according to method as described by Good et al. Total Blood Loss (mL) = 1000 X Hb(loss)/Hb(initial)
Total Hemoglobin Loss
时间窗: Preoperative through Postoperative Days 1 and 2
Total hemoglobin loss estimated using the formula for total blood volume described by Nadler et al Hb(loss) = blood volume (L) x \[Hb(initial)(g/L) - Hb(final)(g/L)\] + Hb(transfused)
Total Drain Output
时间窗: 0-48 hours postoperatively
Total Drain Output as measured postoperatively 0-48 hours
次要结局
- Number of Participants Experiencing Pulmonary Embolism(up to 6-weeks post-operatively)
- Number of Participants Experiencing Myocardial Infarction(up to 6-weeks post-operatively)
- Number of Participants Experiencing Deep Vein Thrombosis(up to 6-weeks post-operatively)
- Number of Participants Experiencing Hematoma as a Surgical Site Complication(up to 6-weeks post-operatively)
- Number of Participants Experiencing Infection as a Surgical Site Complication(up to 6-weeks post-operatively)
研究者
Michael Wiater
MD
William Beaumont Hospitals