Gastro Intestinal Bleeding
Conditions
Brief summary
This study is conducted to evaluate the effectivity of hypertonic dextrose spray as an endoscopic topical hemostatic agent, compared to conventional agent (adrenaline injection, followed by hemoclip or thermocoagulation), in patients with acute non-variceal upper GI bleeding.
Interventions
DRUGDextrose 40 % in Water
injection of adrenaline 1:20.000, followed by dextrose 40% spray
injection of adrenaline 1:20.000, followed by thermocoagulation or hemoclip
PROCEDUREargon plasma coagulation
Thermocoagulation
PROCEDUREHemoclip
Hemoclip
Sponsors
Dr Cipto Mangunkusumo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with acute non-variceal upper gastrointestinal bleeding caused by peptic or duodenal ulcer, polyps, tumors or malignancy * Patients consented to study participation
Exclusion criteria
* Patients with thrombocytopenia (thrombocyte count \<100.000 cells/ul) and other forms of coagulopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemostatic success | 5 minute | Number of participants whose bleeding stops within five minutes after intervention is given. Outcome is assessed by independent assessor (not the endoscopy operator), who also attend the endoscopy session and could observe whether the bleeding stops. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Re-bleeding | 7 days | Number of participants who experience decrease in hemoglobin \>1g/dl or need additional hemostatic endoscopy within one week after intervention |
Countries
Indonesia
Contacts
Primary ContactHasan Maulahela, MD
Outcome results
None listed