An interventional study of tranexamic acid and Placebo in Gastrointestinal Hemorrhage, sponsored by University of Oklahoma. Withdrawn. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-04-09.
Sponsored by University of Oklahoma · Not applicable, Interventional, and Treatment
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.
339 studies on the registry are indexed under Gastrointestinal Hemorrhage; 79 are open to participants now.
Browse Gastrointestinal Hemorrhage studies →University of Oklahoma is the lead sponsor of 424 studies on the registry; 99 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
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All patients with GI bleed if the following criteria are met:
Exclusion Criteria:
Drug: tranexamic acid
Will receive a placebo in place of tranexamic acid treatment
Other: Placebo
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)
Also known as: Cyklokapron
Will receive placebo treatment as per the tranexamic acid schedule
Amount of blood transfusions needed (units of packed RBCs)
Time frame: Every 6 months
Rebleeding events
Time frame: Every 6 months
Need for surgical intervention
Time frame: Every 6 months
Mortality rates
Time frame: Every 6 months
Length of stay in ICU
Time frame: Every 6 months
No study locations are listed for this record.
This study is withdrawn, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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University of Oklahoma