Clinical trial NCT01713101: Tranexamic Acid for Upper Gastrointestinal Bleeding
Official title: Early Administration of Intravenous Tranexamic Acid for Upper Gastrointestinal Bleeding Prior to Endoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Upper Gastrointestinal Hemorrhage
Keywords: Gastrointestinal Hemorrhage
Peptic Ulcer Hemorrhage
Hematemesis
Melena
Tranexamic acid
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-10-24
Enrollment: 414
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 However, the drug is scarcely used nowadays as those studies are outdated in present clinical field where early endoscopic treatment and PPI administration are considered norm.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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients requiring early endoscopic treatment
timeFrame: Within 24 hours of emergency department visit
Secondary outcomes:
measure: Endoscopic signs of bleeding
timeFrame: Within 24 hours of emergency department visit
measure: Length of stay
timeFrame: Within one-month of emergency department visit
measure: Need for urgent endoscopy
timeFrame: Within 24 hours of emergency department visit
measure: Endoscopic procedure time/difficulty
timeFrame: Within 24 hours of emergency department visit
measure: Need for transfusion
timeFrame: Within one-month of emergency department visit
measure: Need for surgery/angiographic intervention
timeFrame: Within one-month of emergency department visit
measure: rate of recurrent bleeding
timeFrame: Within one-month of emergency department visit
measure: death of any cause
timeFrame: Within one-month of emergency department visit
measure: thromboembolic complications
timeFrame: Within one-month of emergency department visit
Other outcomes:
measure: Effect modification by hyperfibrinolysis and other coagulation related factors
timeFrame: Variable (within 24-hour and 1-month of emergency department visit)
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyeongi-do
Study officials:
affiliation: Professor, department of emergency medicine
name: Kyuseok Kim, MD
role: STUDY_DIRECTOR
affiliation: Professor, department of internal medicine (gastroenterology)
name: Sang Hyub Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor, department of internal medicine (gastroenterology)
name: Cheol Min Shin, MD
role: PRINCIPAL_INVESTIGATOR
References: