Bleeding Peptic Ulcers
Conditions
Brief summary
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.
Interventions
DEVICEHemospray
DEVICECombined Conventional Technique
Sponsors
Changi General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Peptic ulcer with high-risk stigmata of recent hemorrhage (Forrest class IA, IB, IIA and IIB)
Exclusion criteria
* Patients younger than 21 years of age * Refusal to participate in study * Contraindicated for endoscopy * Pregnant or lactating patients * Bleeding secondary to non-peptic ulcer source * Patients requiring mechanical ventilation * Patients with acute coronary syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Re-bleeding Within 4 Weeks | 4 weeks | * drop in hemoglobin of at least 2 g/dl, associated with overt signs of GI bleed (melena, and/or hematemesis) * fresh blood hematemesis * melena with a hemodynamic instability (pulse rate \> 100/min, systolic blood pressure \< 90 mm Hg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Initial Hemostasis Rate | Within first endoscopy session | Endoscopically verified cessation of bleeding for at least 5 minutes after treatment. |
Countries
Singapore
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hemospray Hemospray (TC-325, Cook Medical Inc, Winston-Salem, NC, USA), an adsorptive nanopowder hemostatic agent
Hemospray | 10 |
| Combined Conventional Technique Standard dual therapy with saline adrenaline injection and hemoclip / heater probe application
Combined Conventional Technique | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Combined Conventional Technique | Hemospray | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 8 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 2 Participants | 5 Participants |
| Age, Continuous | 72.1 years STANDARD_DEVIATION 11.4 | 67.9 years STANDARD_DEVIATION 18.4 | 70 years STANDARD_DEVIATION 14.9 |
| Region of Enrollment Singapore | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 7 Participants | 9 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 2 / 10 | 0 / 10 |
Outcome results
Primary
Re-bleeding Within 4 Weeks
* drop in hemoglobin of at least 2 g/dl, associated with overt signs of GI bleed (melena, and/or hematemesis) * fresh blood hematemesis * melena with a hemodynamic instability (pulse rate \> 100/min, systolic blood pressure \< 90 mm Hg)
Time frame: 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hemospray | Re-bleeding Within 4 Weeks | 3 Participants |
| Combined Conventional Technique | Re-bleeding Within 4 Weeks | 1 Participants |
Secondary
Initial Hemostasis Rate
Endoscopically verified cessation of bleeding for at least 5 minutes after treatment.
Time frame: Within first endoscopy session
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hemospray | Initial Hemostasis Rate | 9 Participants |
| Combined Conventional Technique | Initial Hemostasis Rate | 10 Participants |