The Use of Hexacapron in Upper Gastrointestinal Bleeding (HEXUGI)

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.

Study Overview

• Status: Unknown
• Conditions: Mortality; Upper Gastrointestinal Bleeding; Hemostasis; Hexacapron; Rebleeding
• Intervention / Treatment: Drug: Hexacapron( Tranexamic acid); Drug: esomeprazole

Detailed Description

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:

1. 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.

2. 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

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 3235
    • Shaare Zedek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment group, hexacapron , esomeprazole; 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); 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.
Placebo Comparator: Standard of care group, esomeprazole; * Standard of care group - receive I.V. esomeprazole 80 mg once then 8mg/h continuously	Drug: esomeprazole; 2. Standard of care group - receive I.V. Esomeprazole 80 mg once and then 8mg/h continuously

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shaare Zedek Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): April 1, 2015
• Study Completion (Anticipated): April 1, 2015

Study Registration Dates

• First Submitted: February 18, 2014
• First Submitted That Met QC Criteria: February 24, 2014
• First Posted (Estimate): February 25, 2014

Study Record Updates

• Last Update Posted (Estimate): February 25, 2014
• Last Update Submitted That Met QC Criteria: February 24, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: hemostasis; upper gastrointestinal bleeding; Hexacapron
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrin Modulating Agents; Gastrointestinal Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Anti-Ulcer Agents; Proton Pump Inhibitors; Tranexamic Acid; Esomeprazole
• Other Study ID Numbers: Hexacap - 1