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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Patients within control group will be given adrenaline 1:20.000 injection, followed by thermocoagulation or hemoclip |
|
| Dextrose group | Experimental | Patients within this group will be given adrenaline 1:20.000 injection, followed by dextrose 40% spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextrose 40 % in Water | Drug | injection of adrenaline 1:20.000, followed by dextrose 40% spray |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemostatic success | 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. | 5 minute |
| Measure | Description | Time Frame |
|---|---|---|
| Re-bleeding | Number of participants who experience decrease in hemoglobin >1g/dl or need additional hemostatic endoscopy within one week after intervention | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hasan Maulahela, MD | Contact | +6281283602549 | hasanmaulahela@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Hasan Maulahela, MD | Dr Cipto Mangunkusumo General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Cipto Mangunkusumo General Hospital | Recruiting | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia |
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| Adrenaline 1 Mg/mL Solution for Injection | Drug | injection of adrenaline 1:20.000, followed by thermocoagulation or hemoclip |
|
| argon plasma coagulation | Procedure | Thermocoagulation |
|
| Hemoclip | Procedure | Hemoclip |
|
| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005947 | Glucose |
| D014867 | Water |
| D004837 | Epinephrine |
| D012996 | Solutions |
| D007267 | Injections |
| D057908 | Argon Plasma Coagulation |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D004564 | Electrocoagulation |
| D002425 | Cautery |
| D006489 | Hemostatic Techniques |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D006488 | Hemostasis, Surgical |
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