Effect of Tranexamic Acid in Upper Gastrointestinal Bleeding



Status:Archived
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:November 2009

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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.


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.


We found this trial at
1
site
Oklahoma City, Oklahoma 73104
?
mi
from
Oklahoma City, OK
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