Impact of Prophylactic Tranexamic Acid on Intra and Postoperational Bleeding Reduction in Patients Undergoing Rhinoplasty Surgery. Low (10mg/kg) and Very Low (5mg/kg) Dose Comparison
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Intraoperational bleeding
研究概览
简要总结
The purpose of this study is to determine whether very low dose of preoperative tranexamic acid (5mg/kg) is as effective as low dose (10mg/kg) for intraoperational bleeding reduction in patients undergoing elective rhinoplasty surgery.
详细描述
Background
Tranexamic acid is a drug registered for bleeding prevention and reduction. It is on the World Health Organisation (WHO) 'essential drugs list'. Preoperative tranexamic acid efficacy is well proved for doses between 10 and 40 mg/kg and last years and decades publications showed that 'low dose' (10mg/kg) is as efficient as higher doses but connected with less adverse effects.
Objectives
To determine whether 5 mg/kg dose is as effective as commonly used 10mg/kg dose in intraoperational bleeding reduction.
Methodology All patients would be randomised into one of two arms - low and very low dose. Patients, investigators and caregivers would be blinded. Patients would receive intravenous bolus of tranexamic acid at 15 minutes before admission to operation theatre in a dose dependent on the study arm. General, intravenous anesthesia (total intravenous anesthesia) would be performed due to hospital standards. At the end of the surgery total blood volume and adverse effects would be noted. Surgeon would asses surgical field in the Fromm scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Blinded (participant, care provider, investigator). Computer block randomisation tool will be used (randomisation.com 1 block, 50 subjects per block), 50 notes with '5 mg/kg' or '10 mg/kg' will be put into sealed envelopes.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age > 18 y.o.
- •American Society of Anesthesiologists Physical Status Classification (ASA) 1-2
- •signed informed consent form after reading the information about the study and talking with one of the investigators
排除标准
- •pregnancy
- •known allergies for tranexamic acid or any other substance in Exacyl
- •deep vein thrombosis
- •Hormone Replacement Therapy or oral contraceptive usage
- •anticoagulants usage
- •obesity - BMI (body mass index) >30 kg/m2
- •renal disease, as glomerular filtration rate (GFR) <60 ml/min/1,73 m*m
- •seizures or epilepsy in the past
研究组 & 干预措施
Very low dose
Will receive single bolus of Tranexamic acid. Dose: 5mg/kg diluted in 0,9% sodium chloride (0,9% NaCl), administered IV (in the vein), 15 min before admission to operation theatre.
干预措施: Tranexamic Acid (Drug)
Very low dose
Will receive single bolus of Tranexamic acid. Dose: 5mg/kg diluted in 0,9% sodium chloride (0,9% NaCl), administered IV (in the vein), 15 min before admission to operation theatre.
干预措施: Sodium Chloride (Drug)
Low dose
Will receive single bolus of Tranexamic acid. Dose: 10mg/kg diluted in 0,9% sodium chloride (0,9% NaCl), administered IV (in the vein), 15 min before admission to operation theatre.
干预措施: Tranexamic Acid (Drug)
Low dose
Will receive single bolus of Tranexamic acid. Dose: 10mg/kg diluted in 0,9% sodium chloride (0,9% NaCl), administered IV (in the vein), 15 min before admission to operation theatre.
干预措施: Sodium Chloride (Drug)
结局指标
主要结局
Intraoperational bleeding
时间窗: during rhinoplasty
it would be assessed at the end of the surgery by measuring blood volume in the suction device and net weight of all surgical material. (precision balance - 2 mg)
次要结局
- Adverse effects(during rhinoplasty and first day after surgery)
- surgical field assesment(during rhinoplasty)
- surgery length(during rhinoplasty)
研究者
Bartłomiej Wódarski
MD
Centre of Postgraduate Medical Education