Tranexamic Acid Use and Blood Loss in Total Hip Arthroplasty

NCT02989155 | Completed

• 1 other identifier: 2015H0427
• Study Type: observational
• Target: 576
• Locations: 1 country
• Sites: 1

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.

Conditions

Tranexamic Acid Use; Blood Loss

Outcome Measures

Primary Outcomes (1)

• hemoglobin, hematocrit, and red blood cell transfusion rates

  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).

  Peri-operative care

Secondary Outcomes (1)

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

  within 30 days of surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicoleta Stoicea, MD, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist/ Adj. Assistant Professor

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 12, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 20, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)