跳至主要内容
临床试验/NCT06421389
NCT06421389已完成不适用

Precise Endoscopic Application of Tranexamic Acid and Sucralfate in Gastrointestinal Bleeding: A Randomized Controlled Trial

National Cheng-Kung University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
the recurrent rate of GI bleeding during the study period

研究概览

简要总结

Background and Aim: Gastrointestinal bleeding (GIB) is a common problem in the hospital. GIB can be divided into upper GIB, small bowel bleeding, and lower GIB. Endoscopic hemostasis includes epinephrine injection, hemoclipping, heat probe coagulation, and Argon plasma coagulation. Although the successful hemostasis rate is high, recurrent bleeding can occur, ranging from 10% to 50% according to the bleeding etiology. Therefore, how to reduce the rebleeding of GIB is an important clinical issue.

Methods: This is a randomized clinical trial. Patients with gastrointestinal bleeding for endoscopy screening and treatment at National Cheng Kung University Hospital were enrolled. The study will recruit 60 patients. After randomization, 30 patients will be classified into the intervention group and 30 into the control group. The participants will receive standard endoscopic hemostasis by either local injection of diluted epinephrine, heater probe coagulation, hemoclipping, or band ligation. After then, we will spray 2g of sucralfate powder and 1g of tranexamic acid through duodenoscopy precisely on the bleeding site in the intervention group. All enrolled patients will be monitored for rebleeding for 28 days after the first endoscopy.

详细描述

Gastrointestinal bleeding (GIB) is a common problem in the hospital. The annual rate of hospitalization for any type of GI hemorrhage is estimated to be 350 hospital admissions/100,000 population. GIB can be divided into upper GIB, small bowel bleeding, and lower GIB. Approximately 50% of admissions for GIB are for UGI bleeding (from the esophagus, stomach, and duodenum), 40% are for LGI bleeding (from the colon and anorectum), and 10% are for small intestine bleeding. Ulceration bleeding, variceal bleeding, angiodysplasia, Dieulafoy lesion, and tumor bleeding are common cause for UGIB, while diverticulosis, colitis, angioectasia, cancer bleeding, and polypectomy ulcer attribute to the LGIB. GI endoscopy can identify the bleeding site and permit therapeutic hemostasis in most patients with GI bleeding.

Endoscopic hemostasis includes epinephrine injection, hemoclipping, heat probe coagulation, and Argon plasma coagulation. Although the successful hemostasis rate is high, recurrent bleeding can occur, ranging from 10% to 50% according to the bleeding etiology. Therefore, how to reduce the rebleeding of GIB is an important clinical issue.

Tranexamic acid (TXA) is a well-known antifibrinolytic agent that inhibits fibrin degradation by binding to tissue plasminogen, thereby preventing blood clot lysis and reducing bleeding. A recent study evaluating the effect of topical tranexamic acid (TXA) powder on bleeding peptic ulcers demonstrated that the precise endoscopic administration of TXA powder can enhance the stop-bleeding effect.

Sucralfate, a complex of aluminum hydroxide and sucrose octa sulfate, can bind to the wound base. This protective barrier can prevent the wound from further environmental injury. Sucralfate has been widely used for wounds and ulcer treatment, e.g., skin wounds, oral ulcers, and peptic ulcers. With the protective effect of the papilla mucosa, sucralfate can cover the wound and has the potential to avoid further environmental damage. In combination with TXA powder in stabilizing the clotting, we expect the rebleeding event will reduce. Therefore, this study aimed to investigate whether the combination therapy of topical administration of TXA and sucralfate after standard endoscopic hemostasis can reduce the rebleeding event.

Furthermore, the adhesion time of the hemostasis powder at the bleeding site is also an unknown issue. High-dose barium enema use provides better clinical outcomes for initial hemostasis and long-term prevention of rebleeding than conservative therapy in LGIB. In combination of barium, the position of hemostasis powder can be identified by Xray.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eligible participants include patients aged ≥ 18 years who accept endoscopy for GIB, including hematemesis, Tarry stool, or bloody stool

排除标准

  • no need of endoscopic hemostasis
  • allergy to sucralfate, tranexamic acid, or barium
  • pregnancy
  • patients with hollow organ perforation

研究组 & 干预措施

Intervention group

Experimental

All patients will receive the standard endoscopic hemostasis by either epinephrine injection, hemoclipping, heat coagulation, or band ligation. After then, patients in intervention group will receive 2g of sucralfate powder, 1g of tranexamic acid powder, and 1g of barium spray through the endoscopy precisely on the bleeding site.

干预措施: Tranexamic Acid Powder (Drug)

结局指标

主要结局

the recurrent rate of GI bleeding during the study period

时间窗: 28 days

Recurrent bleeding was defined as remarkable hematochezia or Tarry stool with endoscopic evidence of the same site bleeding.

次要结局

  • adverse events rate from powder spray(28 days)
  • the rate of rebleeding requiring transarterial embolization or emergency surgery(28 days)
  • length of hospitalization(28 days)
  • all-cause mortality rate(28 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hsueh-Chien Chiang

Attending physician

National Cheng-Kung University Hospital

研究点 (1)

Loading locations...

相似试验