The Use of Hexacapron in Upper Gastrointestinal Bleeding

NCT02071316 | Unknown

• 1 other identifier: Hexacap - 1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Gastrointestinal Bleeding; Hexacapron; Hemostasis; Rebleeding; Mortality

Keywords

upper gastrointestinal bleeding; Hexacapron; hemostasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rebleeding, need for surgery , 30 day mortality

  will be assessed after 30 days from admission to hospital

Study Arms (2)

Treatment group, hexacapron , esomeprazole

ACTIVE COMPARATOR

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)

Standard of care group, esomeprazole

PLACEBO COMPARATOR

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

Drug: esomeprazole

Interventions

Hexacapron( Tranexamic acid) 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.

Treatment group, hexacapron , esomeprazole

esomeprazole DRUG

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

Standard of care group, esomeprazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy, lactation
• History of thromboembolic event
• Allergic reaction to the drug
• Lower gastrointestinal bleeding
• Patient receive anticoagulation treatment
• Receive drug with interaction to hexacapron

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, Israel, 3235, Israel

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.Bernardo Melamud

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: February 25, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: February 25, 2014

Record last verified: 2014-02

Locations

IL (1)