Acute Upper Gastrointestinal Hemorrhage
Conditions
Keywords
Gastrointestinal Hemorrhage, Peptic Ulcer Hemorrhage, Hematemesis, Melena, Tranexamic acid
Brief summary
This study is to see whether the early intravenous administration of tranexamic acid improves the outcome of acute upper gastrointestinal bleeding.
Detailed description
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 However, the drug is scarcely used nowadays as those studies are outdated in present clinical field where early endoscopic treatment and PPI administration are considered norm.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.
Interventions
DRUGEarly intravenous tranexamic acid administration
Initial history taking and physical examination --\> enrollment --\> 1g bolus over 10 minutes followed slow infusion over 8 hours.
DRUGplacebo
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Chief complaint of hematemesis, melena or hematochezia 2. and objective signs of upper gastrointestinal bleeding
Exclusion criteria
1. Pregnant woman, age less than 18 2. Patients whose use of the study drug is contraindicated * Increased thromboembolic risk * History of thromboembolic disease * Alleged inherited thrombophilic disorders * Malignancy (except those cured and has not recurred more than two years) * Nephrotic syndrome * Estrogen use * Pregnancy * HIT, APA * High-risk for cardioembolism * Underlying structural heart disease where anticoagulation is indicated * Underlying cardiac rhythm disorder where anticoagulation is indicated (e.g. atrial fibrillation/flutter) * Possibilities of ongoing DIC * Signs and symptoms suggestive of clinically significant infectious disease (e.g. body temperature \> 38 degree) * Any malignancy except those cured and has not recurred more than two years * 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 3. Previous history of variceal bleeding 4. Cases where informed consent is unobtainable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients requiring early endoscopic treatment | Within 24 hours of emergency department visit |
Secondary
| Measure | 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 | Within 24 hours of emergency department visit |
| Endoscopic procedure time/difficulty | Within 24 hours 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 |
| Need for transfusion | Within one-month of emergency department visit |
Other
| Measure | Time frame | Description |
|---|---|---|
| Effect modification by hyperfibrinolysis and other coagulation related factors | Variable (within 24-hour and 1-month of emergency department visit) | Separate analysis looking into the interaction between coagulation function and tranexamic acid effect |
Countries
South Korea
Contacts
Primary ContactKyuseok Kim, MD
Backup ContactJoonghee Kim, MD
Outcome results
None listed