Effect of Tranexamic Acid 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Effect of Tranexamic Acid on Blood Transfusion in Upper Gastrointestinal Bleeding|
- Amount of blood transfusions needed (units of packed RBCs) [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
- Rebleeding events [ Time Frame: Every 6 months ] [ Designated as safety issue: Yes ]
- Need for surgical intervention [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
- Mortality rates [ Time Frame: Every 6 months ] [ Designated as safety issue: Yes ]
- Length of stay in ICU [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Study Completion Date:||October 2011|
|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
Will receive placebo treatment as per the tranexamic acid schedule
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005147
|Principal Investigator:||Jijo John, MD||University of Oklahoma|
|Principal Investigator:||Gary T. Kinasewitz, MD||University of Oklahoma|