Tranexamic Acid Use and Blood Loss in Total Hip Arthroplasty

NCT ID: NCT02989155

Last Updated: 2017-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

576 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Tranexamic Acid Use Blood Loss

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Nicoleta Stoicea

Research Scientist/ Adj. Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicoleta Stoicea, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2015H0427

Identifier Type: -

Identifier Source: org_study_id

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