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This study is to see whether the early intravenous administration of tranexamic acid improves the outcome of acute upper gastrointestinal bleeding.
Previous studies reported that IV/Oral administration of tranexamic acid improves the outcome upper gastrointestinal bleeding. However, the drug is scarcely used nowadays as those studies are outdated in present clinical field where early endoscopic treatment and PPI administration are considered norm. Although a recent meta-analysis done by Cochrane review group concluded that it improves patient survival, other review articles including "Gut" suggested that a well-designed clinical study is needed for re-evaluation of the efficacy and safety of the drug in current clinical situation. We hypothesized that early administration of the drug will significantly decrease the proportion of patient requiring early endoscopic treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early intravenous tranexamic acid administration | Experimental | Early intraveous administration of tranexamic acid (1g IV bolus over 10 minutes followed by 1g slow infusion over 8 hours |
|
| Placebo group | Placebo Comparator | Normal saline (placebo) administration instead of tranexamic acid solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early intravenous tranexamic acid administration | Drug | Initial history taking and physical examination --> enrollment --> 1g bolus over 10 minutes followed slow infusion over 8 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients requiring early endoscopic treatment | Within 24 hours of emergency department visit |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic signs of bleeding | Within 24 hours of emergency department visit | |
| Length of stay | Within one-month of emergency department visit | |
| Need for urgent endoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Effect modification by hyperfibrinolysis and other coagulation related factors | Separate analysis looking into the interaction between coagulation function and tranexamic acid effect | Variable (within 24-hour and 1-month of emergency department visit) |
Inclusion Criteria:
Exclusion Criteria:
Pregnant woman, age less than 18
Patients whose use of the study drug is contraindicated
Increased thromboembolic risk
High-risk for cardioembolism
Possibilities of ongoing DIC
Patients with history or presence of subarachnoid hemorrhage
Acquired color vision impairment, visual loss and retinal venous and arterial occlusions
Past history of seizure or organic brain lesion that predispose to seizure disorder
Previous history of variceal bleeding
Cases where informed consent is unobtainable
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kyuseok Kim, MD | Contact | +82-31-787-7572 | dremkks@snubh.org | |
| Joonghee Kim, MD | Contact | +82-10-9489-3696 | joonghee@me.com |
| Name | Affiliation | Role |
|---|---|---|
| Kyuseok Kim, MD | Professor, department of emergency medicine | Study Director |
| Sang Hyub Lee, MD | Professor, department of internal medicine (gastroenterology) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Kyeongi-do | South Korea |
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| D010438 | Peptic Ulcer Hemorrhage |
| D006396 | Hematemesis |
| D008551 | Melena |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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|
| placebo | Drug |
|
| Within 24 hours of emergency department visit |
| Endoscopic procedure time/difficulty | Within 24 hours of emergency department visit |
| Need for transfusion | Within one-month of emergency department visit |
| Need for surgery/angiographic intervention | Within one-month of emergency department visit |
| rate of recurrent bleeding | Within one-month of emergency department visit |
| death of any cause | Within one-month of emergency department visit |
| thromboembolic complications | Within one-month of emergency department visit |
| Cheol Min Shin, MD |
| Professor, department of internal medicine (gastroenterology) |
| Principal Investigator |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D014839 | Vomiting |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |