The Use of Hexacapron in Upper Gastrointestinal Bleeding

NCT ID: NCT02071316

Last Updated: 2014-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-04-30

Brief Summary

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

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

Conditions

Upper Gastrointestinal Bleeding; Hexacapron; Hemostasis; Rebleeding; Mortality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Hexacapron( Tranexamic acid)

Intervention Type: DRUG

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.

Standard of care group, esomeprazole

\* Standard of care group - receive I.V. esomeprazole 80 mg once then 8mg/h continuously

Group Type: PLACEBO_COMPARATOR

esomeprazole

Intervention Type: DRUG

2\. Standard of care group - receive I.V. Esomeprazole 80 mg once and then 8mg/h continuously

Interventions

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.

Intervention Type: DRUG

esomeprazole

2\. Standard of care group - receive I.V. Esomeprazole 80 mg once and then 8mg/h continuously

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shaare Zedek Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Dr Bernardo Melamud

Dr.Bernardo Melamud

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shaare Zedek Medical Center

Jerusalem, Israel, Israel

Countries

Israel

Facility Contacts

Bernardo Melamud, Dr.

Role: primary

melamudb@szmc.org.il

00972-2-6666116

Dov Wengrover, Dr.

Role: backup

dwen@szmc.org.il

00972-2-6666067

Other Identifiers

Hexacap - 1

Identifier Type: -

Identifier Source: org_study_id