Tranexamic Acid Use and Blood Loss in Total Hip Arthroplasty

Blood Loss Clinical Trial

Official title:

Tranexamic Acid Use and Blood Loss in Total Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02989155
• Other study ID #: 2015H0427
• Status: Completed
• Phase: N/A
• First received: December 8, 2016
• Last updated: January 18, 2017
• Start date: January 2016
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 576
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss
• Hemorrhage
• Tranexamic Acid Use

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	clinically-significant venous thromboembolism (VTE) and all-cause mortality	frequency of clinically-significant venous thromboembolism (VTE) and all-cause mortality within 30 days of surgery	within 30 days of surgery