Clinical trial NCT02989155: Tranexamic Acid Use and Blood Loss in Total Hip Arthroplasty
Official title: Tranexamic Acid Use and Blood Loss in Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tranexamic Acid Use
Blood Loss
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2016-12-12
Enrollment: 576
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Four surgeons providing total hip replacement services within the date range for data collection have formally agreed to include their patients in the study population, therefore identification of patients will occur through screening the surgery log of each surgeon performing these surgeries within the defined date range.

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.

Eligibility criteria: 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

Primary outcomes:
measure: hemoglobin, hematocrit, and red blood cell transfusion rates
timeFrame: Peri-operative care
Secondary outcomes:
measure: clinically-significant venous thromboembolism (VTE) and all-cause mortality
timeFrame: within 30 days of surgery
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Nicoleta Stoicea, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: