CompletedPhase 4

Oral and Intravenous Tranexamic Acid in Lumbar Spine Surgery

United States83 participantsStarted 2017-02-15

Plain-language summary

The purpose of this project is to compare the effectiveness of two different but well accepted routes of administration of tranexamic acid in order to reduce blood loss and need for transfusion in patients undergoing lumbar spine surgery. Specifically, this study seeks to identify if intravenous tranexamic acid is superior to oral tranexamic acid in reducing blood loss and need for transfusion.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients over age 18 and scheduled for open lumbar spine surgery (primary or revision) * Must be able to swallow tablets Exclusion Criteria * Known allergy to TXA * History of renal failure or kidney transplant * History of arterial thromboembolic event (eg. myocardial infarction, stroke) within the past year * Placement of an arterial stent within the past year * History of blood clots (DVT, PE) within the past year * Refusal to receive blood products

What they're measuring

Intra-operative blood loss between the two groups

Timeframe: Day of surgery to 1 day after surgery, up to 7 days

Trial details

NCT IDNCT03037515

SponsorHenry Ford Health System

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-06-15

View on ClinicalTrials.gov More Blood Loss, Surgical trials