Endoscopic Application of a Hemostatic Powder TC-325 Versus Standard Treatment in the Control of Acute Upper Gastrointestinal Bleeding From Nonvariceal Causes; A Non-inferiority Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- number of participants who presents and confirmed endoscopically as recurrent upper gastro-intestinal bleeding
研究概览
简要总结
Acute upper gastrointestinal bleeding is a common medical emergency. Bleeding peptic ulcers and other non-variceal causes constitute to about 95% of all cases of bleeding. Endoscopic treatment stops active bleeding, reduces rate of further bleeding and leads to improved patients outcomes. Endoscopic treatment can be technically demanding especially with lesions in difficult anatomic positions and to endoscopists with less experience. TC-325 is a propriety mineral blend hemostatic powder used to compress external civilian and military traumatic injuries. Investigators reported the first endoscopic application of TC-325 in 20 patients with actively bleeding gastro-duodenal ulcers. Investigators were able to stop bleeding in 19 of them. Subsequent case series from others reported a similar rate in the acute control of bleeding. To further define the role of TC-325 as a mono-therapy, a comparison to the current standard in endoscopic treatment is required. A non-inferiority randomized trial is being proposed to compare endoscopic use of TC-325 as a mono-therapy to current standards (i.e. hemoclips or thermo-coagulation with or without pre-injection with diluted epinephrine) in hemostatic treatment in patients with acute upper gastrointestinal bleeding from non-variceal causes. The non-inferiority primary endpoint is control of bleeding over 30 days from randomization. Other outcome endpoints include further endoscopic, angiographic or surgical treatments, hospitalization, blood transfusion and mortality. Investigators also compare ease of therapy measured by procedure time and a 10 cm visual analogue scale rated by endoscopists. Endoscopic application of TC-325 is a simple and less skill dependent technique. It may prove useful in bleeding from anatomically challenging sites of the gastro-duodenal tract.
详细描述
Impact and Objectives Long-term impact :Acute upper gastrointestinal bleeding is a common medical emergency. The majority of causes are non-variceal in etiology and are mostly peptic ulcers. Endoscopic treatment reduces further bleeding, surgery and deaths from the condition. The current endoscopic treatment to non-variceal causes includes.the use of hemo-clips and thermo-coagulation. Endoscopic treatment is skill demanding and can be challenging in difficult access areas in the gastroduodenal tract e.g. posterior bulbar duodenum. Endoscopic application of hemostatic powder (labeled TC-325) is technically easy. The proposed randomized trial is the first to compare TC-325 to standard treatment. An non-inferior treatment of hemostatic powder TC-325 would mean wider application of endoscopic treatment as most endoscopists are able to use it. It can at least be used for acute control of bleeding allowing time for more definitive treatment.
Objectives :
- To compare clinical efficacy of the hemostatic powder TC-325 to standard treatment in overall rate of hemostasis in patients with active bleeding from a non-variceal source in the upper gastrointestinal tract. Investigators aim to determine the initial rate of hemostasis and the rate of further bleeding after initial control in both groups. Investigators would like to define role of TC-325 as a mono-therapy when compared to standard treatment. The rate of further bleeding after initial control would also inform us if endoscopic application of TC-325 should be followed by a second look endoscopy with targeted treatment to the bleeding artery.
- To compare ease of application of hemostatic powder TC-325 to standard treatment.
Background of Research, Research Plan and Methodology :
a. Background of research Acute upper gastrointestinal bleeding (AUGIB) is one of the commonest medical emergencies. Mortality in patients with AUGIB remains high. In the National United Kingdom Audit of 2007, the crude overall in patient mortality was 10%. Mortality increases in patients with advanced age and significant comorbid illnesses. Endoscopic therapy greatly improves outcomes in patients with AUGIB. In pooled analyses of randomized controlled trials on endoscopic therapy in patients with nonvariceal upper gastrointestinal bleeding, endoscopic therapy significantly reduces not only further bleeding but also surgery and deaths.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with overt signs of upper gastrointestinal bleeding (hematemesis, melena and/or circulatory instability)
- •documented bleeding (Forrest I) from a non-variceal upper gastrointestinal source (gastro-duodenal ulcers, Mallory Weiss tear, cancers, Dieulafoy's and other vascular lesions) at endoscopy.
排除标准
- •without a full informed consent from the patient or his next of kin
- •Age <18 years
- •Lactating women
研究组 & 干预措施
TC-325
Endoscopic Application of a Hemostatic Powder TC-325, <=150gm , once
干预措施: Endoscopic Application of a Hemostatic Powder TC-325 (Device)
standard treatment
standard treatment of either hemo-clipping or thermo-coagulation with or without pre injection with diluted epinephrine <=20 clip or4 pulse , once only
干预措施: Hemo-clipping (Device)
standard treatment
standard treatment of either hemo-clipping or thermo-coagulation with or without pre injection with diluted epinephrine <=20 clip or4 pulse , once only
干预措施: Epinephrine (Drug)
standard treatment
standard treatment of either hemo-clipping or thermo-coagulation with or without pre injection with diluted epinephrine <=20 clip or4 pulse , once only
干预措施: thermo-coagulation (Device)
结局指标
主要结局
number of participants who presents and confirmed endoscopically as recurrent upper gastro-intestinal bleeding
时间窗: 30 days
( Further bleeding is defined by failure to control bleeding at index endoscopy, renewed hematemesis, fresh melena with circulatory instability after initial control of bleeding (systolic blood pressure of 90 mmHg or less or pulse rate of 110 per minute or more) and/or a drop in haemoglobin by 2 g/dl and haematocrit by 10% over 24 hours despite adequate transfusion. Further bleeding after initial endoscopic hemostasis requires documentation with immediate endoscopy which finds fresh blood and active bleeding from a previously treated upper GIB source. Patients with further bleeding after initial endoscopic control are considered to have reached an outcome endpoint.
次要结局
- number of participants who required further blood transfusion post randomization(30 days)
- number of participants who required subsequent endoscopic treatment upon recurrent bleeding(30 days)
- Days of hospitalization post randomization(60 days)
- Ease of endoscopic treatment as measured by Visual Analog Scale reported by Endoscopist(3 days)
- number of participants who required subsequent surgical treatment upon recurrent bleeding(30 days)
- number of days which participant required caring in Intensive care unit post randomization(60 days)
- number of participants with adverse events as a Measure of Safety and Tolerability (related or unrelated to endoscopic treatment)(30 days)
- number of participants with mortality from all causes within 30 days randomization.(30 days)
- procedure time of endoscopic treatment(3 days)
- number of participant who need extra assistant to accomplish the endoscopic treatment(3 days)
研究者
James Yun-wong Lau
Professor
Chinese University of Hong Kong