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Effect of Tranexamic Acid in Upper Gastrointestinal Bleeding

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ClinicalTrials.gov Identifier: NCT01005147
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : October 30, 2009
Last Update Posted : April 9, 2012
Sponsor:
Information provided by (Responsible Party):
Gary Kinasewitz, University of Oklahoma

Tracking Information
First Submitted Date  ICMJE October 28, 2009
First Posted Date  ICMJE October 30, 2009
Last Update Posted Date April 9, 2012
Study Start Date  ICMJE November 2009
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2009)
Amount of blood transfusions needed (units of packed RBCs) [ Time Frame: Every 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01005147 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Tranexamic Acid in Upper Gastrointestinal Bleeding
Official Title  ICMJE Effect of Tranexamic Acid on Blood Transfusion in Upper Gastrointestinal Bleeding
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Gastrointestinal Hemorrhage
Intervention  ICMJE
  • 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
  • Other: Placebo
    Will receive placebo treatment as per the tranexamic acid schedule
Study Arms  ICMJE
  • Experimental: Tranexamic acid arm
    Intervention: Drug: tranexamic acid
  • Placebo Comparator: Control arm
    Will receive a placebo in place of tranexamic acid treatment
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 5, 2012)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 29, 2009)
36
Actual Study Completion Date  ICMJE October 2011
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01005147
Other Study ID Numbers  ICMJE 14456
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gary Kinasewitz, University of Oklahoma
Study Sponsor  ICMJE University of Oklahoma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jijo John, MD University of Oklahoma
Principal Investigator: Gary T. Kinasewitz, MD University of Oklahoma
PRS Account University of Oklahoma
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP