Can the Prophylactic Administration of Tranexamic Acid Reduce Blood Loss After Robotic-assisted Radical Prostatectomy? The RARPEX (Robotic Assisted Radical Prostatectomy With TranEXamic Acid) Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Reduction of blood loss
研究概览
简要总结
The prophylactic administration of tranexamic acid reduces blood loss during procedures at high risk of perioperative bleeding. Several studies in neurosurgery, cardiac surgery, and orthopedics confirm this finding. The aim of this study is to evaluate the effect of tranexamic acid on peri-and postoperative blood loss and incidence and severity of postoperative complications. A prospective, double-blind, randomized study is conducted to evaluate the effect on several parameters.
Based on pilot study data the investigators decided to include 200 patients in the period from February 2020 to March 2022. The patients will be randomly assigned to study and control groups of 100 patients each. The minimum follow-up will be 3 months.
详细描述
Prostate adenocarcinoma is the second most common malignancy and the second most common cause of death due to malignancy in men. Standard treatment includes radical prostatectomy or radiotherapy in patients with life expectancy for more than 10 years. In recent years, a general tendency toward minimally invasive surgical procedures has been seen. Despite tremendous development in the technology and technique of robotic-assisted radical prostatectomy for more than 25 years, there is still need to look for ways to improve oncological and functional outcomes. Decreasing peri- and postoperative blood loss may lead to faster recovery after the procedure.
Tranexamic acid is an antifibrinolytic used to relieve bleeding. The mechanism of action lies in binding to plasma free plasminogen with higher affinity than tissue plasminogen activator. It prevents its conversion to plasmin, which is responsible for the degradation of fibrin polymers. It results in greater stability of the fibrin clot at the site of bleeding and, therefore, lower blood loss. The use of tranexamic acid during or after the operation does not improve results, unlike administration prior to surgery and the dorsal complex vein is sutured in the beginning of the procedure.
This study is designed to answer the question of whether it might lower the drop in hemoglobin level after the procedure or increase the rate and severity of complications.
This trial was approved by the independent ethics committee at the University Hospital Hradec Kralove (registration number 201903 I90P).
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 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for robotic-assisted radical prostatectomy without pelvic lymph node dissection
- •Signed informed consent provided
- •Body mass index ≤ 35
- •Age of the patient ≤ 75 years
- •Operating surgeon with experience > 100 cases
排除标准
- •Body mass index > 35
- •Age of the patient > 75 years
- •Coagulation disorder (congenital or iatrogenic due to the chronic use of anticoagulants)
- •Thromboembolic, cerebral, or an acute coronary event within the 6 months prior to prostatectomy
- •Chronic renal insufficiency (arbitrary cut-off level of creatinine 200 μmol/l)
- •Allergic reaction to tranexamic acid
- •Operating surgeon with experience < 100 cases
- •Participation in other study
研究组 & 干预措施
Tranexamic acid
干预措施: Tranexamic Acid Injectable Product (Drug)
Saline
干预措施: Placebos (Drug)
结局指标
主要结局
Reduction of blood loss
时间窗: 7 days after the procedure
The drop of hemoglobin level, weighted on gram of prostate or creatinin level.
次要结局
- The risk of postoperative complications(90 days after the procedure)
研究者
Michal Balik
Principal Investigator
University Hospital Hradec Kralove