Comparative Study of the Efficiency of Oral Tranexamic Tcid vs. Oral Tminocaproic Acid to Reduce Blood Loss and Transfusion After Total Knee Replacement. A Prospective, Randomized, Double Blinded Controlled Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Total blood loss (TBL)
研究概览
简要总结
This study compares two oral medications (tranexamic acid and aminocaproic acid) as hemostatic agent administered in patients undergoing total knee replacement.
详细描述
Background
Total knee arthroplasty is the most common orthopedic procedure in knee surgery for the treatment of degenerative diseases such as OA and rheumatoid arthritis (RA), with nearly 700,000 procedures performed in 2012 in the USA. The TKA frequently results in a significant loss of blood in a post-operative manner, which is estimated at more than 1500 ml (Hart et al., 2014). It has been reported that about 20 to 50% of patients under an TKA require a transfusion of allogenic blood. Even so, transfusion is associated with high costs, a high rate of hemolytic and non-hemolytic transfusion reactions, transmission of infectious diseases, high incidence of fluid overload and higher rates of post-operative morbidity and mortality. It has been reported in previous studies that the cost related to the transfusion of a single globular package reaches 1200 dollars (Bierbaum et al., 1999).
Tranexamic acid (AXA) and aminocaproic acid (EACA) are synthetic drugs derived from Lysine that competitively inhibit the lysine receptors in the plasminogen and plasmin activating molecules, preventing the premature dissolution of the clot. These can be administered orally, intravenously or topically. Previous studies of systematic reviews have concluded that the topical and intravenous forms of tranexamic acid significantly decrease bleeding after an TKA (Churchill et al., 2016).
Regarding the administration routes of the drugs in the intravenous form, cases of severe anaphylaxis and / or septic shock have been observed during its administration. The topical form carries the theoretical risk of increasing the rate of periprosthetic infections due to contamination of the needle and could cause sepsis. In the same way, the effects of topical application on the duration of the cement used in the prosthesis has not been determined in studies with long-term follow-up.
There are 3 forms of presentation for the administration of tranexamic acid (oral, topical and intravenous), however the ideal route for its administration remains controversial. Yuan et al. (2017) conducted a study comparing the 3 routes of administration of tranexamic acid during the total replacement of the unilateral primary knee, finding that the three routes are effective in reducing blood loss and the rate of transfusion. In the same way, the oral route of administration proved to be equivalent or even more effective in the total replacement of the knee and hip to reduce blood loss. Similarly from a cost-benefit point of view it has also proven to be superior.
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
- Single (Participant)
盲法说明
Prior to being included in the study, the patient will be mentioned the times when he will receive the medication as well as the dosage of administration (which is the same for each of the two medications). The patient will not know what medication is being administered to him / her. no time The pills will be given to you in a medicine cup without access to any information legend.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years
- •Total replacement of the primary knee due to primary Osteoarthrosis
- •Two-compartment prosthesis
- •Unilateral procedure
- •Cemented prosthesis
- •Desire to participate voluntarily in the study and signature of informed consent
- •Pre-operative assessment with result between ASA I, ASA II or ASA III performed and annexed in the clinical file either by the Department of Internal Medicine, Cardiology or Anesthesiology of our hospital.
- •Possibility for oral administration of the drug.
排除标准
- •History of thrombotic or embolic event in the last 6 months
- •Clinical history of coagulopathy
- •Previous surgeries in the knee to intervene
- •Patients who have received aspirin, platelet or cumarinic antiplatelet agents in the week prior to surgery or NSAIDs two days prior to surgery.
- •History of myocardial infarction, arteriopathy or unstable angina in the 12 months prior to surgery.
- •Those patients whose preoperative assessment corresponds to an ASA IV or the procedure is contraindicated in its preoperative assessment.
- •Total revision knee replacement
- •Total replacement of tumoral knee
- •Total bilateral knee replacement
- •Cognitive deficit
- •Patients who meet the inclusion criteria but do not wish to participate in the study
- •Patients with a diagnosis of Terminal Chronic Kidney Disease or with a serum creatinine higher than 1.47 mg / dl in the preoperative laboratories.
- •Patients with inability to ingest the drug orally.
- •Patients who are pregnant or breast-feeding or who are taking oral contraceptives.
- •Seizure history
- •Hypersensitivity to the active substance or to any of the excipients.
研究组 & 干预措施
Oral Tranexamic Acid
Tranexamic acid will be administered orally three times (administering 2 tablets each time). In the case of tranexamic acid tablets are 650 mg each.
The first administration will be two hours before the induction of anesthesia, the second 6 hours post-surgery and the third 12 hours after surgery. All by oral administration with a drink of water. The medicines will be administered with a volume of 40 ml of water.
For the tranexamic acid a total dose of 3.9 grams (6 tablets) divided between the 3 administrations (1.3 grams each, ie 2 tablets of 650 mg) will be administered.
干预措施: Oral Tranexamic Acid (Drug)
Oral Aminocaproic Acid
Aminocaproic acid will be administered orally three times (administering 2 tablets each time). In the case of aminocaproic acid tablets are 500 mg each.
The first administration will be two hours before the induction of anesthesia, the second 6 hours post-surgery and the third 12 hours after surgery. All by oral administration with a drink of water. The medicines will be administered with a volume of 40 ml of water.
For the aminocaproic acid, a total dose of 3 grams (6 tablets) divided between the 3 administrations (1 gram each, ie 2 tablets of 500 mg) will be administered.
干预措施: Oral Aminocaproic Acid (Drug)
结局指标
主要结局
Total blood loss (TBL)
时间窗: The third day postoperative,at the time of obtaining the result of the hematocrit of 72 hours.
Total blood loss 72 hours after surgery,The Gross and Nadler formula was used to calculate TBL. TBL = patient's blood volume (PBV) x (Hctpre - Hctpost)/Hctave (Hctpre = the initial pre-operative Hct level, Hctpost = the Hct on the morning of POD3). PBV = k1 x height (m) + k2 x weight (kg) + k3 (k1 = 0.3669, k2 = 0.03219, and k3 = 0.6041 for men; and k1 = 0.3561, k2 = 0.03308, and k3 = 0.1833 for women, Hctave = the average of the Hctpre and Hctpost)
External blood loss (EBL)
时间窗: On the second postoperative day (48 hours), when removing the surgical drainage.
External blood loss (EBL) was estimated by adding the intraoperative bleeding and the blood in the drain collectors upon removal after 48 hours
Hidden blood loss (HBL)
时间窗: The third day postoperative
was defined as Total blood loss minus External blood loss
次要结局
- Drainage quantification(Drainage quantification will be registered at 24 and 48 hours postsurgery)
- Intraoperative blood loss(Immediately after the end of the surgery)
- Chage in Hematocrit level(Hematocrit levels will be measured at 24, 48 and 72 hours postsurgery)
- Change in Hemoglobin level(Hemoglobin levels will be measured at 24, 48 and 72 hours postsurgery)
- Therapeutic effect on visual analog scale(The third day postoperative)
- Complications(at 24, 48 and 72 hours, 7 days, 4 and 6 weeks.)
- Transfusion rate(at 24, 48 and 72 hours, 7 days, 4 and 6 weeks.)
研究者
FELIX VILCHEZ CAVAZOS
Professor of Orthopedics and Traumatology
Universidad Autonoma de Nuevo Leon