The Use of Hexacapron in Upper Gastrointestinal Bleeding

Mortality Clinical Trial

— HEXUGI  

Official title:

The Use of Hexacapron in Upper Gastrointestinal Bleeding

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02071316
• Other study ID #: Hexacap - 1
• Status: Not yet recruiting
• Phase: N/A
• First received: February 18, 2014
• Last updated: February 24, 2014
• Start date: April 2014
• Est. completion date: April 2015

Study information

• Verified date: February 2014
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israeli Health Ministry':'
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Hemostasis
• Hexacapron
• Mortality
• Rebleeding
• Upper Gastrointestinal Bleeding

Intervention

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

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No