Gastrointestinal HemorrhageNCT01005147
Effect of Tranexamic Acid in Upper Gastrointestinal Bleeding
A study testing tranexamic acid in people with Gastrointestinal Hemorrhage, run by University of Oklahoma.
Trial summary
The investigators hypothesize that addition of Tranexamic acid, an antifibrinolytic agent, to conventional therapy will lead to an improved outcome characterized by lower transfusion requirements. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastrointestinal Hemorrhage
- What is being tested?
- tranexamic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Oct 2011
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with GI bleed if the following criteria are met:
- has received 4 units of PRBCs within a 24-hour period, or
- has orthostatic hypotension (drop in SBP of 20mmHg or drop in DBP of 10mmHg after fluid resuscitation with at least 20ml/Kg of either isotonic fluid and/or PRBCs), or
- if the MAP remains below 60mmHg after fluid resuscitation, and
- written informed consent is obtained from the subject or legally authorized representative.
Who cannot join
- Pregnant or lactating women
- Known to have gastrointestinal malignancy
- On anticoagulation therapy
- Patients with history of thromboembolism
- Patients with history of myocardial infarction or ischemic cerebrovascular accident
- Patient with end stage renal disease
- Patients with DNR status
- Incarcerated individuals
About this study
Official title: Effect of Tranexamic Acid on Blood Transfusion in Upper Gastrointestinal Bleeding
The investigators hypothesize that addition of Tranexamic acid, an antifibrinolytic agent, to conventional therapy will lead to an improved outcome characterized by lower transfusion requirements.
Read the detailed description
After informed consent is obtained patients will be randomized to receive either Tranexamic acid or placebo in additional to conventional therapy. All patients with gastrointestinal hemorrhage who are admitted to the ICU are managed in consultation with the GI physicians. The ICU team in consultation with the gastroenterology team will manage these patients. Tranexamic acid will be administered in a dose of 1 gm intravenously every 6 hours for four days.
The majority of patients with GI bleeding will spontaneously stop bleeding. However, in those patients that do not and are hemodynamically unstable it poses a significant management challenge. Management of these individuals includes resuscitation followed by endoscopy as well as therapy guided by clinical diagnosis. With optimal therapy mortality in these individuals remains high and the amount of blood transfusion on occasions turns out to be massive and often the outcomes are futile. Tranexamic acid is an antifibrinolytic agent that has been shown to be associated with reduced bleeding and transfusion requirement in surgical patients. We would like to randomize patients to receive either Tranexamic acid or placebo in addition to conventional therapy and monitor outcome.
This study should provide us with information about the efficacy of this medicine in patients with upper GI bleeding. Data from this trial will provide us information about utility of pursuing this modality of therapy.
- Conditions
- Gastrointestinal Hemorrhage
- Being tested
- tranexamic acid, Placebo
- Keywords
- tranexamic acid, upper GI bleeding, blood transfusion, GI bleeding
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tranexamic acidDrug
Also called Cyklokapron
1 gm every 6 hours for 4 days via IV for non-renal impaired subjects. Alternate IV dosing for renally-impaired subjects: 10mg/Kg BID (1.36 - 2.83 mg/dl clearance); 10mg/Kg QD (2.84 - 5.66 mg/dl clearance; and 10mg/Kg Q48H or 5mg/Kg (.5.66mg/dl clearance)
PlaceboOther
Will receive placebo treatment as per the tranexamic acid schedule
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid arm | Experimental | Not described Receives: Drug: tranexamic acid |
| Control arm | Placebo comparator | Will receive a placebo in place of tranexamic acid treatment Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of blood transfusions needed (units of packed RBCs)
Measured: Every 6 months
Secondary outcomes (4)
Rebleeding events
Measured: Every 6 months
Need for surgical intervention
Measured: Every 6 months
Mortality rates
Measured: Every 6 months
Length of stay in ICU
Measured: Every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startNov 2009
- Study completionOct 2011
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal HemorrhageStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary Kinasewitz, University of Oklahoma
- Investigators
- Jijo John, MD, Principal investigator, University of OklahomaGary T. Kinasewitz, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005147
- Sponsor's protocol ID
- 14456
- Status last verified
- Apr 2012
- First submitted
- 28 Oct 2009
- Last updated
- 9 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tranexamic Acid on Blood Transfusion in Upper Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT01005147
- Acronym / sponsor ID
- 14456
- Conditions
- Gastrointestinal Hemorrhage
- Keywords
- tranexamic acid, upper GI bleeding, blood transfusion, GI bleeding
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Nov 2009
- Study completion
- Oct 2011 (actual)
- First posted
- 30 Oct 2009 (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 investigators hypothesize that addition of Tranexamic acid, an antifibrinolytic agent, to conventional therapy will lead to an improved outcome characterized by lower transfusion requirements.
Detailed description
After informed consent is obtained patients will be randomized to receive either Tranexamic acid or placebo in additional to conventional therapy. All patients with gastrointestinal hemorrhage who are admitted to the ICU are managed in consultation with the GI physicians. The ICU team in consultation with the gastroenterology team will manage these patients. Tranexamic acid will be administered in a dose of 1 gm intravenously every 6 hours for four days.
The majority of patients with GI bleeding will spontaneously stop bleeding. However, in those patients that do not and are hemodynamically unstable it poses a significant management challenge. Management of these individuals includes resuscitation followed by endoscopy as well as therapy guided by clinical diagnosis. With optimal therapy mortality in these individuals remains high and the amount of blood transfusion on occasions turns out to be massive and often the outcomes are futile. Tranexamic acid is an antifibrinolytic agent that has been shown to be associated with reduced bleeding and transfusion requirement in surgical patients. We would like to randomize patients to receive either Tranexamic acid or placebo in addition to conventional therapy and monitor outcome.
This study should provide us with information about the efficacy of this medicine in patients with upper GI bleeding. Data from this trial will provide us information about utility of pursuing this modality of therapy.
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 |
|---|---|---|
| Tranexamic acid arm | Experimental | Drug: tranexamic acid |
| Control arm | Placebo comparator | Other: PlaceboWill receive a placebo in place of tranexamic acid treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All patients with GI bleed if the following criteria are met:
Key exclusion criteria (8 listed)
- Pregnant or lactating women
- Known to have gastrointestinal malignancy
- On anticoagulation therapy
- Patients with history of thromboembolism
- Patients with history of myocardial infarction or ischemic cerebrovascular accident
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 |
|---|---|---|
| tranexamic acidAlso: Cyklokapron1 gm every 6 hours for 4 days via IV for non-renal impaired subjects. Alternate IV dosing for renally-impaired subjects: 10mg/Kg BID (1.36 - 2.83 mg/dl clearance); 10mg/Kg QD (2.84 - 5.66 mg/dl clearance; and 10mg/Kg Q48H or 5mg/Kg (.5.66mg/dl clearance) | Drug | Tranexamic acid arm |
| PlaceboWill receive placebo treatment as per the tranexamic acid schedule | Other | Control arm |
Primary outcome
Amount of blood transfusions needed (units of packed RBCs)
Time frame: Every 6 months
4 secondary outcomes
Rebleeding events
Time frame: Every 6 months
Need for surgical intervention
Time frame: Every 6 months
Mortality rates
Time frame: Every 6 months
Length of stay in ICU
Time frame: Every 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2012.
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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.
Jijo John, MD principal investigator
University of Oklahoma
Gary T. Kinasewitz, MD principal investigator
University of Oklahoma
Questions about this trial
What is this clinical trial studying?
A study testing tranexamic acid in people with Gastrointestinal Hemorrhage, run by University of Oklahoma.
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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 9 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of blood transfusions needed (units of packed RBCs) (time frame: Every 6 months). 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 9 Apr 2012.