Tranexamic Acid Use and Blood Loss in Total Hip Arthroplasty

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.

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Key information

Conditions

Tranexamic Acid Use Blood Loss Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Primary outcomes

hemoglobin, hematocrit, and red blood cell transfusion rates

Time frame: 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 outcomes

clinically-significant venous thromboembolism (VTE) and all-cause mortality

Time frame: within 30 days of surgery

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

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Dec 12, 2016
Registry last updated: Jan 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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