Usage of Tranexamic Acid During Colonic Endoscopic Resection Procedures for Reduction Intraprocedural and Postprocedural Bleeding
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Postprocedural bleeding
研究概览
简要总结
Colonoscopy with polypectomy reduces the incidence and mortality associated with colon cancer. However, polypectomy is associated with adverse events such as bleeding. Tranexamic acid (TXA) is a synthetic derivative of lysine that exerts antifibrinolytic effects and may prevent bleeding. The investigators aim to evaluate the effect of local TXA on preventing intraprocedural and postprocedural bleeding in patients undergoing endoscopic mucosal resection (EMR) of large colon polyps.
详细描述
Endoscopic resection (ER) is an endoscopic technique used for the removal of sessile or flat neoplasms confined to the superficial layers (mucosa and submucosa) of the gastrointestinal (GI) tract.
This technique is not without risk, and clinically significant intraprocedural bleeding (CSIPB) and post-ER bleeding (CSPEB) remain the most frequently encountered serious adverse event.
The bleeding rate associated with ER varies for the different regions of the GI tract. This is most probably due to differences in the vascularity within the wall of the GI tract in each region.
For colonic ER, intraprocedural bleeding occurs in about 11% of cases with delayed bleeding up to 11%.
Management of CSIPB and CSPEB is often resource intensive and may necessitate hospitalization, blood transfusion, and repeat intervention. Some techniques, such as soft coagulation with the tip of a snare, epinephrine injection or hemoclip placement are used to decrease the risk of bleeding or treat active bleeding.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred for endoscopic resection of non-neoplastic and neoplastic lesions in the colon presenting to our tertiary academic center.
- •Age > 18 years
排除标准
- •patients with histories of allergic reactions to TXA
- •history of seizures
- •pregnancy
研究组 & 干预措施
Tranexamic Acid group
standard solution for injection with TXA and without adrenaline
干预措施: Tranexamic acid (Drug)
Standard therapy group
standard solution for injection including adrenaline
干预措施: Standard (Drug)
结局指标
主要结局
Postprocedural bleeding
时间窗: Within 2 weeks of procedure
Overt postprocedural bleeding, whether including a drop in hemoglobin or not
次要结局
- Intraprocedural bleeding(During the procedure)
研究者
Anton Bermont
Doctor
Assaf-Harofeh Medical Center