Effect of Tranexamic Acid in Upper Gastrointestinal Bleeding

This study has been withdrawn prior to enrollment.
(No participants enrolled)
Sponsor:
Information provided by (Responsible Party):
Gary Kinasewitz, University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01005147
First received: October 28, 2009
Last updated: April 5, 2012
Last verified: April 2012
  Purpose

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 Intervention
Gastrointestinal Hemorrhage
Drug: tranexamic acid
Other: Placebo

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Amount of blood transfusions needed (units of packed RBCs) [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: November 2009
Study Completion Date: October 2011
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01005147

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

No publications provided

Responsible Party: Gary Kinasewitz, Principal Investigator, University of Oklahoma
ClinicalTrials.gov Identifier: NCT01005147     History of Changes
Other Study ID Numbers: 14456
Study First Received: October 28, 2009
Last Updated: April 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Oklahoma:
tranexamic acid
upper GI bleeding
blood transfusion
GI bleeding

Additional relevant MeSH terms:
Hemorrhage
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014