Upper Gastrointestinal BleedingHEXUGINCT02071316
The Use of Hexacapron in Upper Gastrointestinal Bleeding
A study testing Hexacapron( Tranexamic acid) and esomeprazole in people with Upper Gastrointestinal Bleeding and Hexacapron, run by Shaare Zedek Medical Center at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Gastrointestinal Bleeding, Hexacapron, Hemostasis
- What is being tested?
- Hexacapron( Tranexamic acid) and esomeprazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2014to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy, lactation
- History of thromboembolic event
- Allergic reaction to the drug
- Lower gastrointestinal bleeding
- Patient receive anticoagulation treatment
- Receive drug with interaction to hexacapron
Trial locations and contacts
1 site in 1 country.
Israel1 site
Shaare Zedek Medical Center
Jerusalem, Israel, 3235
Bernardo Melamud, Dr., 00972-2-6666116, melamudb@szmc.org.il
Dov Wengrover, Dr., 00972-2-6666067, dwen@szmc.org.il
About this study
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.
Read the 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:
- 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.
- 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
- Being tested
- Hexacapron( Tranexamic acid), esomeprazole
- Keywords
- upper gastrointestinal bleeding, Hexacapron, hemostasis
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hexacapron( Tranexamic acid)Drug
- 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.
esomeprazoleDrug
- Standard of care group - receive I.V. Esomeprazole 80 mg once and then 8mg/h continuously
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Will be assessed 48 hours after admission to hospital
Secondary outcomes (1)
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
Measured: will be assessed after 30 days from admission to hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Gastrointestinal BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Bernardo Melamud, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071316
- Sponsor's protocol ID
- Hexacap - 1
- Acronym
- HEXUGI
- Status last verified
- Feb 2014
- First submitted
- 18 Feb 2014
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Hexacapron in Upper Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT02071316
- Acronym / sponsor ID
- HEXUGI / Hexacap - 1
- Conditions
- Upper Gastrointestinal Bleeding, Hexacapron, Hemostasis, Rebleeding, Mortality
- Keywords
- upper gastrointestinal bleeding, Hexacapron, hemostasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 25 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group, hexacapron , esomeprazole | Active comparator | Drug: Hexacapron( Tranexamic acid)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. |
| Standard of care group, esomeprazole | Placebo comparator | Drug: esomeprazole* Standard of care group - receive I.V. esomeprazole 80 mg once then 8mg/h continuously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Pregnancy, lactation
- History of thromboembolic event
- Allergic reaction to the drug
- Lower gastrointestinal bleeding
- Patient receive anticoagulation treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Treatment group, hexacapron , esomeprazole |
| esomeprazole2. Standard of care group - receive I.V. Esomeprazole 80 mg once and then 8mg/h continuously | Drug | Standard of care group, esomeprazole |
Primary outcome
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
1 secondary outcome
Rebleeding, need for surgery , 30 day mortality
Time frame: will be assessed after 30 days from admission to hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hexacapron( Tranexamic acid) and esomeprazole in people with Upper Gastrointestinal Bleeding and Hexacapron, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2014.