The Effect of Tranexamic Acid Rate of Administration on Blood Pressure in Healthy Pregnant Women Scheduled for Elective Cesarean Delivery Under Spinal Anesthesia - A Prospective, Randomized, Double-blind, Non-inferiority Trial.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change in systolic blood pressure from baseline over 15 minutes post-TXA administration between groups.
研究概览
简要总结
Tranexamic acid is a well-established treatment for post-partum hemorrhage. This study aims to examine the effect of tranexamic acid administration rates on blood pressure changes over 1 minute compared to 10 minutes in healthy pregnant patients scheduled for cesarean delivery.
详细描述
Women who are clinically diagnosed with post-partum hemorrhage during a vaginal or cesarean delivery should be immediately administered tranexamic acid according to the World Health Organization's recommendation. Tranexamic acid is a drug that inhibits the breakdown of fibrin clots which reduces blood loss. However, due to the risk of hypotension, the product monograph for TXA advises against rapid intravenous (IV) administration. Other clinical studies have also reported an increased incidence of nausea, vomiting, and visual disturbances; nonetheless, the results of these trials suggest that these side effects may be related to properties of TXA rather than the rate of administration. Therefore, the investigators of this study aim to determine if the rate of tranexamic acid administration has an effect on blood pressure in healthy pregnant patients who are scheduled for cesarean delivery under spinal anesthesia.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
An anesthesiologist or anesthesia assistant not involved in the study will draw up TXA and labelling them based on the randomization.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant patients ≥34 weeks gestational age, for elective cesarean delivery under single-shot spinal anesthesia.
- •American Society of Anesthesiologists (ASA) Physical Status Class
- •Patients ≥19 years of age.
排除标准
- •Known history of pre-existing hypertension or hypertension disorders of pregnancy.
- •Having recently taken a medication to treat high blood pressure (e.g. labetolol, hydralazine, nifedipine)
- •Having recently taken a medication that could alter blood pressure, which could include beta those prescribed for anxiety (e.g. propranolol) or sedative pre-medication (e.g. midazolam, lorazepam).
- •Known allergic reaction or hypersensitivity to TXA or any other TXA homologue.
- •Elective cesarean delivery requiring general anesthesia or a neuraxial technique other than a single-shot spinal (e.g. Epidural or Combined Spinal Epidural).
- •Patients who are unable to give informed consent due to a language barrier as the study team only speaks English and will be unable to complete consent process and study procedure appropriately.
- •Patients arriving late to the surgical day care with <90 min prior to scheduled cesarean delivery time resulting in potential delay for the operating room or inadequate time for consent and full execution of the protocol.
研究组 & 干预措施
Slow-rate administration of TXA
This group will be administered tranexamic acid over 10 minutes
干预措施: Tranexamic Acid (TXA) (Drug)
Rapid-rate administration of TXA
This group will be administered tranexamic acid over 1 minute
干预措施: Tranexamic Acid (TXA) (Drug)
结局指标
主要结局
Change in systolic blood pressure from baseline over 15 minutes post-TXA administration between groups.
时间窗: 15 minutes starting from the time of completed TXA administration.
Change in systolic blood pressure from baseline over 15 minutes post-TXA administration between study and control groups
次要结局
- Incidence of hypertension(Up to 4 hours from time of TXA administration until time of discharge from the recovery room)
- Incidence of nausea(Up to 4 hours from time of TXA administration until time of discharge from the recovery room)
- Incidence of vomiting(Up to 4 hours from time of TXA administration until time of discharge from the recovery room)
- Incidence of hypotension(Up to 4 hours from time of TXA administration until time of discharge from the recovery room)
- Incidence of central nervous system side effects(Up to 4 hours from time of TXA administration until time of discharge from the recovery room)
研究者
Anthony Chau
Clinical Associate Professor
University of British Columbia