Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: 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
Brief Summary: 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.


Options:
A: Arm Label: Erythromycin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Erythromycin | Arm Label: Placebo Group endoscopic therapy; Type: NO_INTERVENTION; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Erythromycin; Assigned to Arm(s): Erythromycin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo Group endoscopic therapy
B: Arm Label: Urgent endoscopy; Type: ACTIVE_COMPARATOR; Interventions: Other: Urgent endoscopy | Arm Label: Early endoscopy; Type: PLACEBO_COMPARATOR; Interventions: Other: Early endoscopy | Intervention Type: OTHER; Name: Urgent endoscopy; Assigned to Arm(s): Urgent endoscopy | Intervention Type: OTHER; Name: Early endoscopy; Assigned to Arm(s): Early endoscopy
C: Arm Label: Over-the-scope Clips; Type: EXPERIMENTAL; Interventions: Device: Over-the-scope Clips | Arm Label: standard treatment; Type: ACTIVE_COMPARATOR; Interventions: Device: Hemo-clipping, Device: thermo-coagulation, Drug: Epinephrine | Intervention Type: DEVICE; Name: Over-the-scope Clips; Assigned to Arm(s): Over-the-scope Clips | Intervention Type: DEVICE; Name: Hemo-clipping; Assigned to Arm(s): standard treatment | Intervention Type: DEVICE; Name: thermo-coagulation; Assigned to Arm(s): standard treatment | Intervention Type: DRUG; Name: Epinephrine; Assigned to Arm(s): standard treatment
D: Arm Label: TC-325; Type: EXPERIMENTAL; Interventions: Device: Endoscopic Application of a Hemostatic Powder TC-325 | Arm Label: standard treatment; Type: ACTIVE_COMPARATOR; Interventions: Device: Hemo-clipping, Drug: Epinephrine, Device: thermo-coagulation | Intervention Type: DEVICE; Name: Endoscopic Application of a Hemostatic Powder TC-325; Assigned to Arm(s): TC-325 | Intervention Type: DEVICE; Name: Hemo-clipping; Assigned to Arm(s): standard treatment | Intervention Type: DRUG; Name: Epinephrine; Assigned to Arm(s): standard treatment | Intervention Type: DEVICE; Name: thermo-coagulation; Assigned to Arm(s): standard treatment

Answer: D