View Clinical Trial (Medical Research Study)
Effect of Tranexamic Acid on Blood Transfusion in Upper Gastrointestinal Bleeding
| City: |
|
Oklahoma City |
| State: |
|
Oklahoma |
| Zip Code: |
|
73104 |
| Conditions: |
|
Gastrointestinal Hemorrhage |
| Purpose: |
|
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.
|
| Study Summary: |
|
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.
|
| Criteria: |
|
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
|
| NCT ID: |
|
NCT01005147 |
| Primary Contact: |
|
Principal Investigator
Jijo John, MD
University of Oklahoma
Jijo John, MD
Phone: 405-271-6173
Email: jjohn@ouhsc.edu
|
| Backup Contact: |
|
Email: priscilla-peer@ouhsc.edu
Priscilla Peer, BS
Phone: 405-271-6173 ext. 6
|
| Location Contact: |
|
Oklahoma City, Oklahoma 73104
United States
Jijo John, MD
Phone: 405-271-6173
Email: jijo-john@ouhsc.edu
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 24, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|