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Trial record 63 of 414 for:    shaare zedek

The Use of Hexacapron in Upper Gastrointestinal Bleeding (HEXUGI)

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ClinicalTrials.gov Identifier: NCT02071316
Recruitment Status : Unknown
Verified February 2014 by Dr Bernardo Melamud, Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : February 25, 2014
Last Update Posted : February 25, 2014
Sponsor:
Information provided by (Responsible Party):
Dr Bernardo Melamud, Shaare Zedek Medical Center

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.

Condition or disease Intervention/treatment Phase
Upper Gastrointestinal Bleeding Hexacapron Hemostasis Rebleeding Mortality Drug: Hexacapron( Tranexamic acid) Drug: esomeprazole Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Use of Hexacapron in Upper Gastrointestinal Bleeding
Study Start Date : April 2014
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : April 2015

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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




Primary Outcome Measures :
  1. Prevention of rebleeding manifested as hematemesis, melena and drop in hemoglobin level by 2g% within 24 hours after therapeutic endoscopy [ Time Frame: Will be assessed 48 hours after admission to hospital ]
    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


Secondary Outcome Measures :
  1. Rebleeding, need for surgery , 30 day mortality [ Time Frame: will be assessed after 30 days from admission to hospital ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02071316


Locations
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Israel
Shaare Zedek Medical Center Not yet recruiting
Jerusalem, Israel, 3235
Contact: Bernardo Melamud, Dr.    00972-2-6666116    melamudb@szmc.org.il   
Contact: Dov Wengrover, Dr.    00972-2-6666067    dwen@szmc.org.il   
Sub-Investigator: Alon Scwartz, Dr.         
Sub-Investigator: Michael Newman, Dr.         
Sponsors and Collaborators
Shaare Zedek Medical Center

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Responsible Party: Dr Bernardo Melamud, Dr.Bernardo Melamud, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT02071316     History of Changes
Other Study ID Numbers: Hexacap - 1
First Posted: February 25, 2014    Key Record Dates
Last Update Posted: February 25, 2014
Last Verified: February 2014

Keywords provided by Dr Bernardo Melamud, Shaare Zedek Medical Center:
upper gastrointestinal bleeding
Hexacapron
hemostasis

Additional relevant MeSH terms:
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Hemorrhage
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Tranexamic Acid
Esomeprazole
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors