Comparative Study of Tranexamic Acid Dosage Regimens in Patients Undergoing Cardiac Surgery Under Cardiopulmonary Bypass
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- duration of inhibition of fibrinolysis as measured by the ClotPro-TPA test
研究概览
简要总结
Tranexamic axid is routinely used as an antifibrinolytic agent in cardiac surgery to reduce the risk of blood loss and transfusion. However, there is no consensus regarding the dosage regimen of tranexamic acid that should be administered. The purpose of this study is to compare different dosages of tranexamic acid in cardiac surgery using cardiopulmonary bypass regarding the duration of inhibition of fibrinolysis as measured by the ClotPro test.
Blood samples will be taken from the arterial line placed in the patient at specified time points in order to perform viscoelastic tests (ClotPro, TPA test), to detect successful inhibition of fibrinolysis and to measure tranexamic acid levels in the patient's blood. In case the action of tranexamic acid stops early postoperatively an additional dose of the medication will be administered to the patient.
详细描述
Excessive bleeding and blood transfusions are common in patients undergoing cardiac surgery. Antifibrinolytic therapy reduces the risk of blood loss and transfusion among patients undergoing cardiac surgery. Tranexamic acid is an antifibrinolytic agent that forms a reversible complex with plasminogen. Guidelines for the management of bleeding in patients recommend the routine use of tranexamic acid for cardiac surgery in adults. However, there is no consensus regarding the dosage regimen of tranexamic acid that should be administered. More specifically, several dosage regimens have been studied in the literature. Although higher doses of tranexamic acid achieve a marginal reduction in postoperative bleeding, they increase the risk of drug-related postoperative complications. Based on a recent 2021 meta -analysis, it appears that lower doses of tranexamic acid (eg 20 mg / kg or 10mg/kg followed by 1mg kg-1 h-1) are safe and effective. In the literature, the duration of inhibition of fibrinolysis after the administration of tranexamic acid has been studied using the point of care test ClotPro (a thromboelastometry analyzer) in relatively large dosages (total dose: 50 mg / kg), while there are no relevant randomized clinical studies. Lower doses of tranexamic acid have been shown to be effective and safe, although their duration of action has not been studied using the viscoelastic Clot Pro-TPA test and their correlation with blood tranexamic acid concentration.
The present study aims to evaluate different dosages of tranexamic acid in cardiac surgery using cardiopulmonary bypass. The primary outcome is the duration of inhibition of fibrinolysis as measured by the ClotPro test and the correlation of imprinting with tranexamic blood concentration.
Methods:
Perioperative management will follow standard department practice. Patients for elective cardiac surgery using cardiopulmonary bypass will be randomized to receive tranexamic acid after induction of anesthesia at three different doses of 30 mg / kg , 20 mg / kg or 10 mg / kg followed by 1 mg / kg / h until the end of the surgery. All patients will sign an informed consent prior to their inclusion in the study.
Data collection:
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective cardiac surgery using cardiopulmonary bypass
- •Patients to have discontinued anticoagulant and antiplatelet therapy preoperatively according to guidelines.
排除标准
- •Age below 18 years
- •Patient refusal
- •Pregnancy
- •End-stage renal disease
- •History of epilepsy,
- •Cardiac surgery without the use of cardiopulmonary bypass (off-pump)
- •Emergency operations
- •Known allergy to the administered agents.
研究组 & 干预措施
Group 1
Group 1 will receive a tranexamic acid dosage of 10mg/kg prior to operation start, followed by transfusion rate of 1mg/kg/h until the end of the surgery.
干预措施: Tranexamic acid at a dose of 10 mg/kg followed by 1 mg/kg/h (Drug)
Group 2
Group 2 will receive a tranexamic acid dosage of 20mg/kg prior to operation start.
干预措施: Tranexamic acid at a dose of 20 mg/kg (Drug)
Group 3
Group 3 will receive a tranexamic acid dosage of 30mg/kg prior to operation start.
干预措施: Tranexamic acid at a dose of 30 mg/kg (Drug)
结局指标
主要结局
duration of inhibition of fibrinolysis as measured by the ClotPro-TPA test
时间窗: time(hours) from tranexamic acid administration until the values of ML and LT in the TPA test (Clot Pro) become greater than 50% and less than 2100 sec, respectively,up to 240 hours post tranexamic acid bolus administration.
time(hours) from tranexamic acid administration until the values of ML and LT in the TPA test (Clot Pro) become greater than 50% and less than 2100 sec, respectively (0,3,6,12,24,36,48 etc up to 240 hours post tranexamic acid bolus administration).
tranexamic blood concentration
时间窗: time(hours) from tranexamic acid administration until the values of ML and LT in the TPA test (Clot Pro) become greater than 50% and less than 2100 sec, respectively, and up to up to 240 hours post tranexamic acid bolus administration.
Blood concentration of tranexamic acid at predifined study time points (0,3,6,12,24,36,48 etc up to 240 hours post tranexamic acid bolus administration)
次要结局
- transfusion of blood and products(Ιntraoperatively and during the first 24 hours postoperatively)
- need of administration of coagulation factors(intraoperatively and during the first 24 hours postoperatively)
- reoperation(From the end of surgery until the patient's discharge from the hospital or death (up to 1 year))
- Postoperative bleeding(During the first 24 hours postoperatively)
- postoperative incidence of seizures(From the administration of tranexamic acid until the patient's discharge from the hospital (up to 1 month))
- Mechanical ventilation(From the end of surgery until the patient's extubation, or patient's death if not extubated. (up to 1 year))
- Length of stay in the Intensive Care Unit(From the end of surgery until the patient's discharge from the ICU, or patient's death if not discharged. (up to 1 year))
- Length of hospitalization(From the day of surgery until the patient's discharge from the hospital, or patient's death if not discharged. (up to 1 year))
- All cause in-hospital mortality(From the day of surgery until the patient's discharge from the hospital (up to 1 year))
- thrombotic episodes(From the administration of tranexamic acid until the patient's discharge from the hospital. (up to one month))
研究者
Evangelia Samara
Assistant Professor of Anaesthesiology
University of Ioannina