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Effect of Tranexamic Acid in Upper Gastrointestinal Bleeding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01005147
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : October 30, 2009
Last Update Posted : April 9, 2012
Information provided by (Responsible Party):
Gary Kinasewitz, University of Oklahoma

Brief 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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Hemorrhage Drug: tranexamic acid Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Tranexamic Acid on Blood Transfusion in Upper Gastrointestinal Bleeding
Study Start Date : November 2009
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Tranexamic acid arm Drug: tranexamic acid
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)
Other Name: Cyklokapron

Placebo Comparator: Control arm
Will receive a placebo in place of tranexamic acid treatment
Other: Placebo
Will receive placebo treatment as per the tranexamic acid schedule

Primary Outcome Measures :
  1. Amount of blood transfusions needed (units of packed RBCs) [ Time Frame: Every 6 months ]

Secondary Outcome Measures :
  1. Rebleeding events [ Time Frame: Every 6 months ]
  2. Need for surgical intervention [ Time Frame: Every 6 months ]
  3. Mortality rates [ Time Frame: Every 6 months ]
  4. Length of stay in ICU [ Time Frame: Every 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01005147

Sponsors and Collaborators
University of Oklahoma
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Principal Investigator: Jijo John, MD University of Oklahoma
Principal Investigator: Gary T. Kinasewitz, MD University of Oklahoma

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Responsible Party: Gary Kinasewitz, Principal Investigator, University of Oklahoma Identifier: NCT01005147    
Other Study ID Numbers: 14456
First Posted: October 30, 2009    Key Record Dates
Last Update Posted: April 9, 2012
Last Verified: April 2012
Keywords provided by Gary Kinasewitz, University of Oklahoma:
tranexamic acid
upper GI bleeding
blood transfusion
GI bleeding
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action