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Hemospray (TC-325, Cook Medical Inc, Winston-Salem, NC, USA), a new adsorptive nanopowder hemostatic agent for endoscopic treatment of high-risk bleeding peptic ulcers, provides significant ease of administration compared to the combined conventional technique of saline-adrenaline injection with mechanical clip or heater probe applications. The Hemospray powder is easily applied on ulcers at difficult endoscopic positions and ulcers with fibrotic bases, where the combined conventional technique has limited efficacy. Building up on preliminary work from small single-arm studies, the investigators aim to establish the efficacy and safety of Hemospray in treating bleeding peptic ulcers in comparison with the combined conventional technique. The investigators propose a pilot study to establish our centre's feasibility of performing a prospective, randomized, parallel group trial, which compares the efficacy of Hemospray with the combined conventional technique, in the endoscopic treatment of high-risk bleeding peptic ulcers. Patients with high-risk bleeding peptic ulcers will be treated with Hemospray to determine its initial hemostasis rate (defined as endoscopically verified cessation of bleeding for at least 5 minutes after endoscopic treatment), rebleeding rate (recurrent hemorrhage during a 4-week period following the initial hemostasis) and its safety profile.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemospray | Experimental | Hemospray (TC-325, Cook Medical Inc, Winston-Salem, NC, USA), an adsorptive nanopowder hemostatic agent |
|
| Combined Conventional Technique | Active Comparator | Standard dual therapy with saline adrenaline injection and hemoclip / heater probe application |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemospray | Device |
| ||
| Combined Conventional Technique |
| Measure | Description | Time Frame |
|---|---|---|
| Re-bleeding Within 4 Weeks |
| 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Initial Hemostasis Rate | Endoscopically verified cessation of bleeding for at least 5 minutes after treatment. | Within first endoscopy session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Kwek, MBBS | Changi General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changi General Hospital | Singapore | Singapore |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hemospray | Hemospray (TC-325, Cook Medical Inc, Winston-Salem, NC, USA), an adsorptive nanopowder hemostatic agent Hemospray |
| FG001 | Combined Conventional Technique | Standard dual therapy with saline adrenaline injection and hemoclip / heater probe application Combined Conventional Technique |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hemospray | Hemospray (TC-325, Cook Medical Inc, Winston-Salem, NC, USA), an adsorptive nanopowder hemostatic agent Hemospray |
| BG001 | Combined Conventional Technique | Standard dual therapy with saline adrenaline injection and hemoclip / heater probe application Combined Conventional Technique |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Re-bleeding Within 4 Weeks |
| Posted | Count of Participants | Participants | 4 weeks |
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hemospray | Hemospray (TC-325, Cook Medical Inc, Winston-Salem, NC, USA), an adsorptive nanopowder hemostatic agent Hemospray |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Respiratory, thoracic and mediastinal disorders | COD pneumonia following surgery for retroperitoneal extension of duodenal ulcer. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Andrew Kwek Boon Eu | Changi General Hospital | 6788 8833 | andrew_kwek@cgh.com.sg |
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|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Initial Hemostasis Rate | Endoscopically verified cessation of bleeding for at least 5 minutes after treatment. | Posted | Count of Participants | Participants | Within first endoscopy session |
|
|
|
| 1 |
| 10 |
| 2 |
| 10 |
| 0 |
| 10 |
| EG001 | Combined Conventional Technique | Standard dual therapy with saline adrenaline injection and hemoclip / heater probe application Combined Conventional Technique | 0 | 10 | 0 | 10 | 0 | 10 |
|
| Acute Myocardial Infarction | Cardiac disorders |
|
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