Effect of Tranexamic Acid on Intraoperative Blood Loss in Patients Undergoing Aquablation for Benign Prostatic Hyperplasia: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Perioperative Hemoglobin Change
研究概览
简要总结
This study aims to find out if tranexamic acid (TXA), a medication, works to decrease blood loss during a specific surgery called Aquablation therapy, which is a treatment for men with Benign Prostatic Hyperplasia (BPH). BPH is a common condition in men over the age of 45 that involves enlargement of the prostate gland and can lead to problems or discomfort with urination.
The main goal of this research is to see if TXA can help reduce the amount of blood loss during surgery compared to not using the drug. This is important because losing less blood during surgery can help patients recover faster and more safely. Researchers will monitor the safety of TXA and its effects on other outcomes, like the length of hospital stay and any possible changes in blood tests that check how well blood clots.
Participants in this study will:
- Be males diagnosed with BPH who are already scheduled to undergo Aquablation therapy.
- Be randomly assigned to either receive TXA or a placebo (a look-alike substance that contains no drug) right before their surgery.
- Not know which treatment they are receiving to make sure the results are unbiased.
Researchers hope to engage participants who meet the health criteria of the study. They will be carefully monitored before, during, and after the surgery for any health changes, and their blood loss during surgery will be measured.
This study does not require any additional time commitment outside of the standard surgical process, and all treatments will be provided at no additional cost to the participants. The researchers will ensure that all participants understand the procedure and support their safety throughout the research.
详细描述
This clinical study is investigating whether a medication called tranexamic acid (TXA) can help reduce blood loss during a type of prostate surgery known as Aquablation therapy. This therapy is used to treat Benign Prostatic Hyperplasia (BPH), a common condition in older men that results in the enlargement of the prostate gland which can cause difficulty with urination.
Purpose of the Study:
The primary purpose of this research is to determine if TXA makes this surgery safer by decreasing the amount of blood lost during the procedure. Reducing blood loss during surgery is beneficial because it can lead to quicker recovery times and reduce the likelihood of complications. The study will also look at other important factors such as the overall safety of using TXA, its effect on the length of time participants stay in the hospital after surgery, and whether it causes any significant changes in blood clotting tests.
How the Research Will Happen:
Participants in the study will be men diagnosed with BPH who are planning to undergo Aquablation therapy. They will be randomly placed into one of two groups:
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)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male participants diagnosed with BPH scheduled for Aquablation therapy.
- •Aged 45 years or older
- •Exhibiting clinically significant symptoms of BPH.
排除标准
- •History of or high risk for thrombosis.
- •Presence of preoperative heart or cerebrovascular diseases.
- •Renal insufficiency.
- •Ongoing anticoagulation therapy.
- •Required extended preoperative resting period.
- •Diagnosis of prostate cancer.
- •Any form of blood coagulation dysfunction.
- •Previous use of warfarin or aspirin before the surgery.
- •Belonging to vulnerable populations such as prisoners (who are not treated in our clinics).
研究组 & 干预措施
Placebo
Participants will receive an intravenous (IV) administration of a placebo prior to their Aquablation procedure. This placebo is a saline solution that looks identical to the tranexamic acid (TXA) used in the Intervention Group but contains no active medication. The placebo is given to mimic the administration of TXA to ensure that the study conditions are the same for both groups, except for the active treatment. All other aspects of the surgical procedure and postoperative care remaining standardized across both study arms.
干预措施: Placebo (Drug)
TXA Administration
Participants receive tranexamic acid (TXA) preoperatively via intravenous (IV) administration. The dose consists of 1g of TXA delivered in a single IV push immediately prior to the Aquablation therapy. TXA acts as an antifibrinolytic agent, preventing excessive blood loss by stabilizing the formation of blood clots during surgery. This intervention aims to assess TXA's efficacy in reducing perioperative blood loss compared to placebo, with all other aspects of the surgical procedure and postoperative care remaining standardized across both study arms.
干预措施: Tranexamic Acid (IV) (Drug)
结局指标
主要结局
Perioperative Hemoglobin Change
时间窗: Measured preoperatively and postoperatively, within 2 hours of surgery completion
The primary outcome measure is the efficacy of tranexamic acid (TXA) in decreasing the amount of hemoglobin lost during Aquablation therapy compared to placebo. This will be quantitatively assessed by measuring the hemoglobin levels in patients' blood samples collected immediately before and after the procedure. The change in hemoglobin levels will be compared between the TXA-treated group and the placebo group to determine if TXA administration results in a significantly smaller decrease in hemoglobin, indicating less blood loss.
次要结局
- Rate of Perioperative Complications Associated with Tranexamic Acid(From initiation of surgery to post-operative follow up, up to 60 days post-surgery.)
- Length of Hospital Stay Post-Aquablation Therapy(From time of surgery to hospital discharge, typically within 1 day post-surgery)
- Change in ProThrombin Time (PT) Following Tranexamic Acid Administration(Lab values measured preoperatively and within 2 hours post-surgery.)
- Change in activated partial thromboplastin time (aPTT) Following Tranexamic Acid Administration(Lab values measured preoperatively and within 2 hours post-surgery.)
- Change in activated fibrinogen level Following Tranexamic Acid Administration(Lab values measured preoperatively and within 2 hours post-surgery.)