Effect of Tranexamic Acid in Upper Gastrointestinal Bleeding

NCT ID: NCT01005147

Last Updated: 2012-04-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2011-10-31

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.

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.

Conditions

Gastrointestinal Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Tranexamic acid arm

Group Type: EXPERIMENTAL

tranexamic acid

Intervention Type: DRUG

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)

Control arm

Will receive a placebo in place of tranexamic acid treatment

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Will receive placebo treatment as per the tranexamic acid schedule

Interventions

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)

Intervention Type: DRUG

Placebo

Will receive placebo treatment as per the tranexamic acid schedule

Intervention Type: OTHER

Other Intervention Names

Cyklokapron

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Gary Kinasewitz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jijo John, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Gary T. Kinasewitz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Other Identifiers

14456

Identifier Type: -

Identifier Source: org_study_id