Tranexamic Acid Use and Blood Loss in Total Hip Arthroplasty

Completed

• Conditions: Tranexamic Acid Use; Blood Loss

• Registration Number: NCT02989155
• Lead Sponsor: Ohio State University

Brief Summary

The purpose of this study is to determine the need for a blood transfusion during surgery and to evaluate the levels of certain proteins in the blood when given tranexamic acid.

Detailed Description

A review of the medical record between January 01 2013 to July 1st 2015 will be used to determine if the hypothesis that patients receiving tranexamic acid will have a lower need for blood transfusion and there are changes in the levels of the proteins essential for healthy oxygen transport throughout the body is correct. Tranexamic acid is a medication which may help wounds to stop bleeding more quickly. Participants are not expected to receive any direct benefits from participating in this study. Only a small risk of private patient medical information being exposed is anticipated. The results of this study will help surgeons and the medical community to better understand the uses of this type of drug and its possible role in benefiting hip replacement patients during and following surgery.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Study First Submitted: 2016-12-08
• Study First Submitted QC: 2016-12-08
• Study First Posted: 2016-12-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 576

Inclusion Criteria

• Adult patients 18 years of age and older
• Surgical patients who underwent primary total hip arthroplasty (THA)
• Surgical patients who underwent revision THA
• Preoperative hemoglobin values (N) 11 g/dl
• Normal international normalized ratio (INR), prothrombin time (PT), partial thromboplastin time (PTT) values

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Exclusion Criteria

• • Allergy to tranexamic acid
• Bilateral THA
• History of ischemic heart disease
• Severe chronic heart failure
• Hepatic dysfunction
• Chronic renal failure
• On hemodialysis
• Cerebral infarction
• History of seizure
• Bleeding disorder
• Anticoagulant or aspirin-like medication and long acting NSAID medication
• Short acting NSAID's were discontinued at least 24 hrs before surgery

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
hemoglobin, hematocrit, and red blood cell transfusion rates	Peri-operative care	Whether intraoperative dose of 2gr tranexamic acid (TXA) in patients having primary or revision THA would decrease the perioperative and post-operative reduction in hemoglobin, hematocrit, and red blood cell transfusion rates compared with those of a similar group of patients who did not receive TXA (control group).

Secondary Outcome Measures

Name	Time	Method
clinically-significant venous thromboembolism (VTE) and all-cause mortality	within 30 days of surgery	frequency of clinically-significant venous thromboembolism (VTE) and all-cause mortality within 30 days of surgery

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States