Prevention of Bleeding and Edema in Bimaxillary Orthognathic Surgery; the Effectiveness of Tranexamic Acid on Intraoperative Bleeding and Postoperative Swelling in Orthognathic Surgery.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Intra-operative bleeding volume (ml)
研究概览
简要总结
Purpose of the study:
- To evaluate the effect of tranexamic acid (TXA) of intraoperative blood loss in patients subjected to bi-maxillary orthognathic surgery
- To evaluate the potential effect of TXA on fibrin structure
- To evaluate the potential effect of TXA of binding of plasminogen to fibrin
- To evaluate the potential effect of TXA on postoperative edema formation.
Hypothesis:
H0: Intraoperative bleeding cannot be significantly reduced by preoperative administration of tranexamic acid
H0,1: Postoperative edema cannot be significantly reduced by preoperative administration of tranexamic acid
详细描述
The study population consists of patients referred to simultaneous mandibular and maxillary osteotomy at the Department of Oral and Maxillofacial Surgery, Hospital of South West Denmark in 2014.
Hundred patients (50 men and 50 women) will be enrolled in the study. Reportedly, the mean intraoperative blood loss in the placebo group is expected to be 436 ml with a standard deviation of 208 ml. The difference in blood loss between the TXA-group and the placebo group to be detected is 100 ml. The dropout frequency is estimated to 10%. To fulfil these assumptions a minimum of 40 patients should be included in each group to reach a power of 0.8 and an alpha of 0.05. In order to accommodate an even gender distribution a block randomization is performed resulting in the randomization of 100 patients.
The patients will be randomized to receive blindly either 10 ml tranexamic acid (100 mg/ml) (Pfizer, Ballerup, Denmark) or 10 ml saline (9mg/ml) preoperatively. Intraoperative blood loss will be determined by deducting the total volume of irrigation fluids from the volume of the contents of the surgical suction device. Postoperative edema formation will be determined by 3D surface scanning and volumetric analysis will be carried out in the "Landmarker" software.
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
- 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
- 是
入选标准
- •Patients must be 18 years or older
- •Patients must be eligible for elective bi-maxillary orthognathic surgery
- •No severe reduction of kidney function
- •No known medical conditions
- •Signed informed consent
排除标准
- •Hypersensitivity to tranexamic acid
- •A medical history of acute venous thrombosis and/or arterial thrombosis
- •The presence of fibrinolytic conditions as a result of disseminated intravascular coagulation, with the exception of a predominant activation of the fibrinolytic system with acute severe bleeding.
- •Severe kidney deficiency
- •Cramps in the medical history
- •Intake of Omega-3 fatty acids, Gingko Biloba, ginger and garlic supplements within 3 months of surgery.
- •Pregnancy (female participants will be tested on the day of surgery)
研究组 & 干预措施
Tranexamic acid
The active comparator consists of an intravenously administered bolus injection of 10ml of 100mg/ml tranexamic (1g in total) given as a single dose, after the onset of anesthesia, prior to surgery.
干预措施: Tranexamic Acid (Drug)
Saline
The placebo consists of an intravenously administered bolus injection of 10 ml of 9mg/ml sodium chloride given as a single dose after the onset of anesthesia, prior to surgery.
干预措施: Saline (Drug)
结局指标
主要结局
Intra-operative bleeding volume (ml)
时间窗: Within 10 minutes after ended surgery
次要结局
- Change in inflammatory profile(Baseline, 5.5 hours, 48 hours and 4 months postoperatively)
- Change in hemostatic profile(Baseline, 5.5 hours, 48 hours and 4 months postoperatively)
- Postoperative edema formation(48 hours and 4 months postoperatively)
研究者
Jesper Jared Olsen
DDS
Esbjerg Hospital - University Hospital of Southern Denmark