Tranexamic Acid in Rhinoplasty: Perioperative Bleeding, Edema and Ecchymosis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Intraoperative bleeding as measured by the volume of blood in suction canister
研究概览
简要总结
This study will be a prospective randomized study to evaluate the effect of tranexamic acid (TXA) use on intraoperative and postoperative outcomes among patients undergoing rhinoplasty by two Facial Plastic surgeons at Vanderbilt. Outcomes will include intra- and post-operative bleeding and postoperative bruising and swelling.
详细描述
TXA is an antifibrinolytic agent that acts to decrease bleeding by stabilizing the fibrin matrix involved in the clotting cascade. The use of TXA, oral or intravenous, has been extensively used and described in the literature to prevent exsanguination in trauma and in various surgical procedures, as well as for heavy menstrual bleeding. It has been used in the perioperative period during various nasal and sinus surgery, and current research in rhinoplasty suggests that its use may decrease intraoperative bleeding and postoperative eye swelling and bruising.
Currently, IV TXA is used at this institution in some cases by some surgeons in the perioperative period in rhinoplasty surgery, though its used is not standardized and has not been studied. This study will randomize patients undergoing rhinoplasty, with consent, to receive TXA or placebo in the perioperative period. The investigators anticipate collecting 60-100 patients. Outcomes will include intraoperative bleeding, postoperative swelling and bruising (both subjective and based on blinded reviewer analysis of postoperative photographs).
TXA has been used in the perioperative period during various nasal and sinus surgery, and current research in rhinoplasty suggests that its use may decrease intraoperative bleeding and postoperative eye swelling and bruising. In these studies, TXA has been given in intravenous and/or oral form in 1-3 doses in the perioperative period, and there have been no serious adverse effects reported. IV TXA is also FDA approved for use at time of tooth extraction to decrease bleeding, and PO TXA is approved use during the menstrual cycle to decrease heavy menstrual bleeding. There are countless studies in the literature supporting use of both IV and PO TXA in trauma, orthopedic and spine surgery and neurosurgery, and it is widely used in clinical practice in these disciplines. It's use in rhinoplasty is growing, yet has not been studied in larger groups.
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
- None
盲法说明
Provider will order tranexamic acid based based on even versus odd last digit of medical record number (MRN). Patient will be blinded, as will all personnel analyzing postoperative photographs and other data.
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
- •Adults at least 18 years of age who elect to undergo cosmetic or functional open primary rhinoplasty with osteotomies (repositioning the nasal bones) by Drs. Yang or Patel at VUMC.
- •No other facial plastics procedure nor sinus surgery performed simultaneously
- •Lack all the below
排除标准
- •Exclusion Criteria:
- •Known allergy to TXA (tranexamic acid)
- •Intracranial bleeding
- •Known defective color vision
- •History of venous or arterial thromboembolism
- •Active thromboembolic disease
- •Severe renal impairment (diagnosis of chronic kidney disease)
- •History of coagulation disorder
- •Known thrombocytopenia (platelets <150,000)
- •Current use of anticoagulant (blood thinner)
- •Uncontrolled DM (diabetes mellitus) preventing use of dexamethasone in the perioperative period
- •Cardiac arrhythmia
- •History of AMI (acute myocardial infarction), stroke, seizure, liver failure
- •Laboratory results showing platelets <150,000, PT (prothrombin time) >45, INR (international normalized ratio) >1.2, seizure disorder
研究组 & 干预措施
Tranexamic Acid
Patients receive 1 gram IV tranexamic acid in the operating room prior to surgical incision.
干预措施: Tranexamic acid (Drug)
结局指标
主要结局
Intraoperative bleeding as measured by the volume of blood in suction canister
时间窗: Intraoperative
Volume of blood in suction canister (Milliliters)
Intraoperative bleeding as measured by the weight of surgical sponges used
时间窗: During surgery
Weight of surgical sponges used (grams)
Postoperative edema
时间窗: Up to one week following surgery
Swelling around the eyes (Visual Analog Scale, 1 to 5 scale with 5 being the most)
Postoperative bleeding as measured by the number of medical interventions needed to control bleeding
时间窗: Up to one week following surgery
Number of interventions required to control bleeding (surgical or procedural interventions)
Postoperative bleeding as measured by patient-rated bleeding on Visual Analog Scale (VAS)
时间窗: Up to one week following surgery.
A single patient-answered question visual analog scale (VAS) used to measure the amount of post-operative bleeding from the nose the participant experienced (1 to 5 scale with 5 being the most)
Postoperative ecchymosis
时间窗: Up to one week following surgery
Bruising around the eyes (Visual Analog Scale, 1 to 5 scale with 5 being the most)
次要结局
未报告次要终点
研究者
Shiayin Yang
Assistant Professor of Otolaryngology
Vanderbilt University Medical Center