Local Infiltration of TranExamic Acid in Surgical Management of Pelvic Organ Prolapse: a Pilot Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 36
- 主要终点
- Intraoperative quantitative blood loss QBL (mL)
研究概览
简要总结
Tranexamic acid (TXA) has been demonstrated to reduce blood loss in trauma, orthopedic, cardiac, and plastic surgeries in numerous well-designed and adequately powered studies. As a result of this evidence for benefit, TXA is routinely used to reduce blood loss during these surgeries. There are no studies regarding the use of TXA in urogynecology. The investigators seek to explore the effect and safety of local infiltration of TXA in vaginal reconstructive surgery.
详细描述
This is a multicenter, double blinded, pilot randomized clinical trial that will be conducted at UTMB Health, and other participating sites. Each participating site will obtain IRB approval. Women with symptomatic, stage II to IV Pelvic organ prolapse (POP) who plan colpocleisis will be approached to participate. Using the study protocol inclusion and exclusion criteria, patient's eligibility will be determined. All eligible subjects will provide the written informed consent before any research data is collected. All screening assessment will be completed at a preoperative, in-person, clinic visit, and within 60 days of surgery. The subject will then undergo randomization to the local TXA, or Vasopressin, or NS group with the total sample size of 36 female subjects (12 per group). Concomitant procedures for POP or urinary incontinence are permitted and will be based upon the operating surgeons' standard clinical practice and best clinical judgement. The anesthesia team is responsible for preparing the study agents, monitoring intraoperative cardiovascular parameters (blood pressure and heart rate) as well as adverse events, and determining the blood transfusion if needed. Subsequently, the subject will have postoperative follow up at 2 weeks and 6 weeks
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)
盲法说明
The attending anesthesiologist will receive the randomized assignment from the lead research team at UTMB and prepare the diluted study agents. The OR staff, attending surgeon, and learners including fellows and residents are blinded.
入排标准
- 年龄范围
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females who are menopausal at the time of consent
- •Able to understand and read English
- •Able and willing to provide written informed consent
- •Able to comply with the follow-up study protocol, per clinician judgment
- •Symptomatic POP (bulge or pressure) evidenced with vaginal prolapse with POP-Q measurement consistent with Stage II-IV
- •LeFort or complete colpocleisis as desired surgical approach to correct POP with and without other concomitant procedures
- •History of abdominal or vaginal surgery for POP
- •American Society of Anesthesiologists (ASA) physical status I or II
排除标准
- •Texas Department of Criminal Justice prisoners
- •Refusal of blood products (e.g, Jehovah's witnesses)
- •ASA physical status III or IV
- •Known allergy or hypersensitivity to TXA or any of the ingredients
- •Subarachnoid hemorrhage
- •Active intravascular clotting, thromboembolic disease (cerebral thrombosis, deep vein thrombosis, or pulmonary embolism)
- •Epilepsy, seizure disorders requiring anti-epileptic medication(s)
- •Acquired impaired color vision (color blindness, retinal involvement)
- •Intrinsic risk of thrombosis or thromboembolism (hypercoagulopathy, thrombogenic cardiac rhythm disease, thrombogenic valvular disease)
- •History of severe liver disease
- •Known allergy or hypersensitivity to 8-L-arginine vasopressin or chlorobutanol
- •History of cardiac diseases (decompensated congestive heart failure CHF, recent coronary artery disease CAD within 30 days, recent myocardial infarction MI within 30 days)
- •History of reversible nephrogenic diabetes insipidus
- •History of primary pelvic organ cancer (uterine, ovarian, endometrial, cervical, bladder) or any cancer that is metastatic to the pelvis
- •Prior or current pelvic radiation, or chemotherapy.
- •Females who desires to have vaginal sexual intercourse after the surgery
研究组 & 干预措施
Normal Saline (NaCl 0.9%)
Local infiltration of 50 cc NaCl 0.9% into the vaginal submucosa during colpocleisis dissection
干预措施: NaCl 0.9% (Other)
Tranexamic Acid (2 mg/dL)
Local infiltration of 50 cc Tranexamic Acid (2 mg/dL) into the vaginal submucosa during colpocleisis dissection
干预措施: Tranexamic acid (Drug)
Vasopressin (0.1 U/dL)
Local infiltration of 50 cc Vasopressin (0.1 U/dL) into the vaginal submucosa during colpocleisis dissection
干预措施: Vasopressin (Drug)
结局指标
主要结局
Intraoperative quantitative blood loss QBL (mL)
时间窗: Intraoperatively
Compare intraoperative QBL during colpocleisis with the local infiltration of Tranexamic acid to the current standard of care, vasopressin or normal saline.
次要结局
- Rate of transfusion(Intraoperatively and 2 weeks postoperatively)
- Colpocleisis operative time (min)(Intraoperatively)
- Intraoperative hear rate (beats/min)(Intraoperatively)
- Postoperative complications(2 weeks and 6 weeks postoperatively)
- Intraoperative blood pressure (mmHg)(Intraoperatively)