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Upper gastrointestinal hemorrhage is a frequently diagnosis in emergency departments. Although new drugs and endoscopic techniques were easily applied in various settings in this condition, the role of local administered therapies such as antifibrinolytic agents remain unclear. The investigators aimed to compare standard therapy (proton pump inhibitors, endoscopic treatments etc.) and standard therapy + local administered tranexamic acid in upper gastrointestinal hemorrhage in a double-blind, randomized trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic acid 5% | Active Comparator | Tranexamic acid 5%, 2000 mg (40 mL) in 60 mL normal saline (0.9%) solution (total 100 mL) |
|
| Placebo | Placebo Comparator | 0.9% normal saline solution (total 100 mL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid 5% | Drug | Via nasogastric tube, 100 mL |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | In- or out of hospital mortality | One month |
| Re-bleeding | Recurrent upper gastrointestinal hemorrhage | One month |
| Endoscopic intervention need | One month | |
| Surgical intervention need | One month | |
| ED revisit | One month |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay in the hospital | One month | |
| Administered blood products in the ED | One month | |
| Adverse reactions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nurettin Özgür Doğan, M.D., Assoc. Prof. | Kocaeli University, Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kocaeli University, Faculty of Medicine | Kocaeli | 41050 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11511559 | Background | Hawkey GM, Cole AT, McIntyre AS, Long RG, Hawkey CJ. Drug treatments in upper gastrointestinal bleeding: value of endoscopic findings as surrogate end points. Gut. 2001 Sep;49(3):372-9. doi: 10.1136/gut.49.3.372. | |
| 7018048 | Background | Bergqvist D, Dahlgren S, Hessman Y. Local inhibition of the fibrinolytic system in patients with massive upper gastrointestinal hemorrhage. Ups J Med Sci. 1980;85(2):173-8. doi: 10.3109/03009738009179185. |
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| Placebo |
| Drug |
Via nasogastric tube, 100 mL |
|
Thromboembolic events, anaphylaxis |
| One month |
| 4122561 | Background | Cormack F, Chakrabarti RR, Jouhar AJ, Fearnley GR. Tranexamic acid in upper gastrointestinal haemorrhage. Lancet. 1973 Jun 2;1(7814):1207-8. doi: 10.1016/s0140-6736(73)90525-4. No abstract available. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |