Effect of Tranexamic Acid in Upper Gastrointestinal Bleeding

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Tranexamic Acid on Blood Transfusion in Upper Gastrointestinal Bleeding

Conditions
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Gastrointestinal Hemorrhage

Intervention / Treatment
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* Drug: tranexamic acid
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic acid arm<br> | Drug: tranexamic acid<br>* 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)<br>* Other names: Cyklokapron;|
| Placebo Comparator: Control arm<br>Will receive a placebo in place of tranexamic acid treatment | Other: Placebo<br>* Will receive placebo treatment as per the tranexamic acid schedule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of blood transfusions needed (units of packed RBCs) |  | Every 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rebleeding events |  | Every 6 months | 
| Need for surgical intervention |  | Every 6 months | 
| Mortality rates |  | Every 6 months | 
| Length of stay in ICU |  | Every 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tranexamic acid, upper GI bleeding, blood transfusion, GI bleeding