Acute Upper Gastrointestinal HemorrhagePhase 3TAUGIBNCT01713101
Tranexamic Acid for Upper Gastrointestinal Bleeding
A Phase 3 study testing Early intravenous tranexamic acid administration in people with Acute Upper Gastrointestinal Hemorrhage, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study is to see whether the early intravenous administration of tranexamic acid improves the outcome of acute upper gastrointestinal bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Upper Gastrointestinal Hemorrhage
- What is being tested?
- Early intravenous tranexamic acid administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 414 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2012to Aug 2015
- Phase
- Phase 3
- 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
- Chief complaint of hematemesis, melena or hematochezia
- and objective signs of upper gastrointestinal bleeding
Who cannot join
- Pregnant woman, age less than 18
- Patients whose use of the study drug is contraindicated
- Increased thromboembolic risk
- History of thromboembolic disease
- Alleged inherited thrombophilic disorders
- Malignancy (except those cured and has not recurred more than two years)
Show all 21Show fewer
- Nephrotic syndrome
- Estrogen use
- Pregnancy
- HIT, APA
- High-risk for cardioembolism
- Underlying structural heart disease where anticoagulation is indicated
- Underlying cardiac rhythm disorder where anticoagulation is indicated (e.g. atrial fibrillation/flutter)
- Possibilities of ongoing DIC
- Signs and symptoms suggestive of clinically significant infectious disease (e.g. body temperature > 38 degree)
- Any malignancy except those cured and has not recurred more than two years
- Patients with history or presence of subarachnoid hemorrhage
- Acquired color vision impairment, visual loss and retinal venous and arterial occlusions
- Past history of seizure or organic brain lesion that predispose to seizure disorder
- Previous history of variceal bleeding
- Cases where informed consent is unobtainable
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Kyeongi-do
Kyuseok Kim, MD, +82-31-787-7572, dremkks@snubh.org
Joonghee Kim, MD, +82-10-9489-3696, joonghee@me.com
About this study
Official title: Early Administration of Intravenous Tranexamic Acid for Upper Gastrointestinal Bleeding Prior to Endoscopy
This study is to see whether the early intravenous administration of tranexamic acid improves the outcome of acute upper gastrointestinal bleeding.
Read the detailed description
Previous studies reported that IV/Oral administration of tranexamic acid improves the outcome upper gastrointestinal bleeding. However, the drug is scarcely used nowadays as those studies are outdated in present clinical field where early endoscopic treatment and PPI administration are considered norm. Although a recent meta-analysis done by Cochrane review group concluded that it improves patient survival, other review articles including "Gut" suggested that a well-designed clinical study is needed for re-evaluation of the efficacy and safety of the drug in current clinical situation. We hypothesized that early administration of the drug will significantly decrease the proportion of patient requiring early endoscopic treatment.
- Conditions
- Acute Upper Gastrointestinal Hemorrhage
- Being tested
- Early intravenous tranexamic acid administration, placebo
- Keywords
- Gastrointestinal Hemorrhage, Peptic Ulcer Hemorrhage, Hematemesis, Melena, Tranexamic acid
- Medical subject headings
- Gastrointestinal Hemorrhage, Peptic Ulcer Hemorrhage, Hematemesis, Melena
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early intravenous tranexamic acid administrationDrug
Also called tranexamic acid administration, transamine administration, antifibrinolytics administration
Initial history taking and physical examination --> enrollment --> 1g bolus over 10 minutes followed slow infusion over 8 hours.
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Early intravenous tranexamic acid administration | Experimental | Early intraveous administration of tranexamic acid
(1g IV bolus over 10 minutes followed by 1g slow infusion over 8 hours Receives: Drug: Early intravenous tranexamic acid administration |
| Placebo group | Placebo comparator | Normal saline (placebo) administration instead of tranexamic acid solution Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients requiring early endoscopic treatment
Measured: Within 24 hours of emergency department visit
Secondary outcomes (9)
Endoscopic signs of bleeding
Measured: Within 24 hours of emergency department visit
Length of stay
Measured: Within one-month of emergency department visit
Need for urgent endoscopy
Measured: Within 24 hours of emergency department visit
Endoscopic procedure time/difficulty
Measured: Within 24 hours of emergency department visit
Need for transfusion
Measured: Within one-month of emergency department visit
Need for surgery/angiographic intervention
Measured: Within one-month of emergency department visit
rate of recurrent bleeding
Measured: Within one-month of emergency department visit
death of any cause
Measured: Within one-month of emergency department visit
thromboembolic complications
Measured: Within one-month of emergency department visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Upper Gastrointestinal HemorrhageStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 414 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyuseok Kim, MD, Study director, Professor, department of emergency medicineSang Hyub Lee, MD, Principal investigator, Professor, department of internal medicine (gastroenterology)Cheol Min Shin, MD, Principal investigator, Professor, department of internal medicine (gastroenterology)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713101
- Sponsor's protocol ID
- B-1207-163-002
- Acronym
- TAUGIB
- Status last verified
- May 2014
- First submitted
- 18 Oct 2012
- Last updated
- 16 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Administration of Intravenous Tranexamic Acid for Upper Gastrointestinal Bleeding Prior to Endoscopy
- ClinicalTrials.gov ID
- NCT01713101
- Acronym / sponsor ID
- TAUGIB / B-1207-163-002
- Conditions
- Acute Upper Gastrointestinal Hemorrhage
- Keywords
- Gastrointestinal Hemorrhage, Peptic Ulcer Hemorrhage, Hematemesis, Melena, Tranexamic acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 414 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 24 Oct 2012 (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.
This study is to see whether the early intravenous administration of tranexamic acid improves the outcome of acute upper gastrointestinal bleeding.
Detailed description
Previous studies reported that IV/Oral administration of tranexamic acid improves the outcome upper gastrointestinal bleeding. However, the drug is scarcely used nowadays as those studies are outdated in present clinical field where early endoscopic treatment and PPI administration are considered norm. Although a recent meta-analysis done by Cochrane review group concluded that it improves patient survival, other review articles including "Gut" suggested that a well-designed clinical study is needed for re-evaluation of the efficacy and safety of the drug in current clinical situation. We hypothesized that early administration of the drug will significantly decrease the proportion of patient requiring early endoscopic treatment.
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 |
|---|---|---|
| Early intravenous tranexamic acid administration | Experimental | Drug: Early intravenous tranexamic acid administrationEarly intraveous administration of tranexamic acid (1g IV bolus over 10 minutes followed by 1g slow infusion over 8 hours |
| Placebo group | Placebo comparator | Drug: placeboNormal saline (placebo) administration instead of tranexamic acid solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chief complaint of hematemesis, melena or hematochezia
- and objective signs of upper gastrointestinal bleeding
Key exclusion criteria (21 listed)
- Pregnant woman, age less than 18
- Patients whose use of the study drug is contraindicated
- Previous history of variceal bleeding
- Cases where informed consent is unobtainable
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 |
|---|---|---|
| Early intravenous tranexamic acid administrationAlso: tranexamic acid administration, transamine administration, antifibrinolytics administrationInitial history taking and physical examination --> enrollment --> 1g bolus over 10 minutes followed slow infusion over 8 hours. | Drug | Early intravenous tranexamic acid administration |
| placebo | Drug | Placebo group |
Primary outcome
Proportion of patients requiring early endoscopic treatment
Time frame: Within 24 hours of emergency department visit
9 secondary outcomes
Endoscopic signs of bleeding
Time frame: Within 24 hours of emergency department visit
Length of stay
Time frame: Within one-month of emergency department visit
Need for urgent endoscopy
Time frame: Within 24 hours of emergency department visit
Endoscopic procedure time/difficulty
Time frame: Within 24 hours of emergency department visit
Need for transfusion
Time frame: Within one-month of emergency department visit
Need for surgery/angiographic intervention
Time frame: Within one-month of emergency department visit
rate of recurrent bleeding
Time frame: Within one-month of emergency department visit
death of any cause
Time frame: Within one-month of emergency department visit
thromboembolic complications
Time frame: Within one-month of emergency department visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
Related trials for Acute Upper Gastrointestinal Hemorrhage
Recruiting
Fexuprazan for Prevention of Upper Gastrointestinal Bleeding in High Bleeding Risk Patients Receiving Dual Antiplatelet Therapy
Acute Coronary Syndromes (ACS), Coronary Artery Disease (CAD)
Recruiting
Detection of Blood in the GI Lumen With HemoPill Acute
Upper GI Bleeding
Active, not recruiting
Timing of Endoscopy in Cirrhotic Patients With Acute Variceal Bleeding
Acute Upper Gastrointestinal Bleeding, Acute Variceal Bleeding
RecruitingPhase 4
Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy
Coronary Artery Disease, Percutaneous Coronary Intervention
Not yet recruiting
Terlipressin vs. Somatostatin in Cirrhotic Patients With Acute Variceal Bleeding and Renal Dysfunction
Liver Cirrhosis
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.
Kyuseok Kim, MD study director
Professor, department of emergency medicine
Sang Hyub Lee, MD principal investigator
Professor, department of internal medicine (gastroenterology)
Cheol Min Shin, MD principal investigator
Professor, department of internal medicine (gastroenterology)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Early intravenous tranexamic acid administration in people with Acute Upper Gastrointestinal Hemorrhage, run by Seoul National University Hospital at 1 site in South Korea.
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 2 inclusion and 21 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 16 May 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 South Korea. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Kyuseok Kim, MD (+82-31-787-7572, dremkks@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients requiring early endoscopic treatment (time frame: Within 24 hours of emergency department visit). 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 16 May 2014.