Effect of Tranexamic Acid in Upper Gastrointestinal Bleeding

Gastrointestinal Hemorrhage Clinical Trial

Official title:

Effect of Tranexamic Acid on Blood Transfusion in Upper Gastrointestinal Bleeding

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01005147
• Other study ID #: 14456
• Status: Withdrawn
• Phase: N/A
• First received: October 28, 2009
• Last updated: April 5, 2012
• Start date: November 2009
• Est. completion date: October 2011

Study information

• Verified date: April 2012
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage

Intervention

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:
• Placebo
Will receive placebo treatment as per the tranexamic acid schedule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of blood transfusions needed (units of packed RBCs)		Every 6 months	No
Secondary	Rebleeding events		Every 6 months	Yes
Secondary	Need for surgical intervention		Every 6 months	No
Secondary	Mortality rates		Every 6 months	Yes
Secondary	Length of stay in ICU		Every 6 months	No