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Effect of Tranexamic Acid in Upper Gastrointestinal Bleeding

NCT01005147 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2012-04-09

No results posted yet for this study

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.

Conditions

  • Gastrointestinal Hemorrhage

Interventions

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

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Jijo John, MD · University of Oklahoma

  • Gary T. Kinasewitz, MD · University of Oklahoma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Completion
2011-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01005147 on ClinicalTrials.gov