The Use of Hexacapron in Upper Gastrointestinal Bleeding

Study Overview
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Brief Summary
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The purpose of this study is to conduct a randomized control trial, double-blind study to compare Hexacapron with standard of care treatment to standard of care alone to evaluate the efficacy of adding effect of Hexacapron to standard therapy by decreasing the episodes of rebleeding and mortality in patient with upper gastrointestinal bleeding.

Detailed Description
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Research Objectives To evaluate the efficacy of using hexacapron in treatment of upper gastrointestinal bleeding Primary outcome: Prevention of rebleeding manifested as hematemesis, melena and drop in hemoglobin level by 2g% within 24 hours after therapeutic endoscopy Secondary outcomes: rebleeding, need for surgery , 30 day mortality Expected Significance- The sample size needed to detect a 10% absolute difference in the proportion of rebleeding, drop in hemoglobin by 2g% between the hexacapron treated group and standard of care group groups with 80% power and 0.05 significant levels(alpha). Research methods: Prospective , randomized controlled trial , double blinded , single center Duration : 2 years   300≤ participants ,18≤ years of age Patients 18≤ years of age admitted to emergency department in Shaare Zedek Medical Center with clinical signs and symptoms of upper gastrointestinal bleeding will receive initial resuscitation and stabilization maintaining blood pressure and intravascular volume. Patients will be randomized to 3 groups: Treatment group - receive I.V. Esomeprazole 80 mg once and then 8mg/h continuously with concurrent hexacapron I.V. every 6 hours until 72 hours and then the patient continue oral treatment 6 g /day for 7 days. Standard of care group - receive I.V. Esomeprazole 80 mg once and then 8mg/h continuously Every patient will undergo upper endoscopy within 12 hours of admission to emergency department and receive treatment according to the endoscopic findings If no reason for bleeding will be found in upper endoscopy , treatment will be stopped and patient will be excluded Every participant will fill a questionnaire with informed consent which will have to be signed. If cannot sign due to his medical condition or disability his guardian will sign or first degree relative Study population: Patients 18≤ years of age admitted to emergency department in Shaare Zedek MedicalCenter with clinical signs and symptoms of upper gastrointestinal bleeding including hematemesis, melena and drop in hemoglobin level by 2g% Included: Patients 18≤ years of age admitted to emergency department in Shaare Zedek Medical Center with clinical signs, symptoms and laboratory of upper gastrointestinal bleeding Hospitalized patients in Shaare Zedek Medical Center with clinical signs, symptoms and laboratory of upper gastrointestinal bleeding • Patients , guardian or family member who can sign on informed consent Excluded: Pregnancy, lactation History of thromboembolic event Allergic reaction to the drug Lower gastrointestinal bleeding Patient receive anticoagulation treatment Receive drug with interaction to hexacapron

Official Title
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The Use of Hexacapron in Upper Gastrointestinal Bleeding

Conditions
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Upper Gastrointestinal Bleeding, Hexacapron, Hemostasis, Rebleeding, Mortality

Intervention / Treatment
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* Drug: Hexacapron( Tranexamic acid)
* Drug: esomeprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18≤ years of age admitted to emergency department in Shaare Zedek MedicalCenter with clinical signs, symptoms and laboratory of upper gastrointestinal bleeding Hospitalized patients in Shaare Zedek Medical Center with clinical signs, symptoms and laboratory of upper gastrointestinal bleeding Patients , guardian or family member who can sign on informed consent Exclusion Criteria: Pregnancy, lactation History of thromboembolic event Allergic reaction to the drug Lower gastrointestinal bleeding Patient receive anticoagulation treatment Receive drug with interaction to hexacapron

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment group, hexacapron , esomeprazole<br>Treatment group - receive I.V. esomeprazole 80 mg and 8mg/h continuously with concurrent hexacapron I.V. every 6 hours until 72 hours and then continue oral treatment 6 g /day for 7 days. | Drug: Hexacapron( Tranexamic acid)<br>* 1. Treatment group - receive I.V. Esomeprazole 80 mg once and then 8mg/h continuously with concurrent hexacapron( Tranexamic acid) I.V. every 6 hours until 72 hours and then the patient continue oral treatment 6 g /day for 7 days.<br>|
| Placebo Comparator: Standard of care group, esomeprazole<br>* Standard of care group - receive I.V. esomeprazole 80 mg once then 8mg/h continuously | Drug: esomeprazole<br>* 2. Standard of care group - receive I.V. Esomeprazole 80 mg once and then 8mg/h continuously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of rebleeding manifested as hematemesis, melena and drop in hemoglobin level by 2g% within 24 hours after therapeutic endoscopy | All patients will undergo upper endoscopy within 12 hours from admission to assess their cause of upper GI bleeding .Patients will be evaluated according to the intervention group or standard of care group if there is another episode of bleeding or not during the first 48 hours after the first bleeding episode or within 24 hours after the first endoscopy was done | Will be assessed 48 hours after admission to hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rebleeding, need for surgery , 30 day mortality | All patients will be assessed for more bleeding episodes (>2 episodes) , need fo surgery or mortality during the 30 days after the first bleeding episode | will be assessed after 30 days from admission to hospital | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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upper gastrointestinal bleeding, Hexacapron, hemostasis