Intra-articular Tranexamic Acid in the Reduction of Blood Transfusions in Primary Total Hip and Total Knee Arthroplasty

April 6, 2017 updated by: Orthopaedic Innovation Centre

Role of Low Dose Intra-articular Tranexamic Acid in the Reduction of Blood Transfusions in Primary Total Hip and Total Knee Arthroplasty: A Randomized Placebo Controlled Study

This is a randomized, double blinded, controlled trial in patients undergoing elective Total Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA). The study group will receive intra-articular Tranexamic Acid (TXA) while the control group will receive normal saline placebo.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary purpose of this study is to determine if intra-articular administration of low dose TXA following THA and TKA results in a clinically relevant reduction in blood loss. The secondary purpose is to determine if there is an increased risk of thromboembolic phenomena with the use of TXA following elective THA and TKA. The primary outcome metric will be - drop in hemoglobin following surgery; secondary metrics include blood loss, transfusion rate, d-dimers, troponin levels, symptomatic deep venous thrombosis (DVT) and pulmonary embolism (PE), vascular events (myocardial infarction, stroke), major and minor bleeding, and death.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2K 3S8
        • Concordia Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • with osteoarthritis
  • scheduled for elective primary unilateral THR or TKR
  • provided informed consent
  • can read, write and speak English

Exclusion Criteria:

  • history of arterial or venous thromboembolic disease (myocardial infarction, symptomatic ischemic heart disease, atrial fibrillation, cerebrovascular accident, deep-vein thrombosis, pulmonary embolus, or thrombogenic cardiac valvular disease or rhythm disease)
  • pre-operative Hg of <120 g/L
  • Known allergy to Tranexamic Acid
  • Coagulation disorder
  • Acquired disturbances of color vision
  • Hepatic insufficiency, any history of liver disease
  • Renal insufficiency (on dialysis)
  • Preoperative prophylactic use of antiplatelet or anticoagulant therapy such as Clopidogrel, Warfarin, dabigatran or Rivaroxaban. This does not include low dose Aspirin (81mg)
  • Patients with a history of subarachnoid hemorrhage [20]
  • Simultaneous bilateral THA or TKA
  • Any contra-indication for spinal anesthesia
  • Allergy to Celecoxib, which will be the only nonsteroidal anti-inflammatory drugs (NSAID) used in the multi-modal analgesia regime.
  • Retinal vein or retinal artery occlusion
  • Female on oral contraceptive pills and/or premenopausal
  • Concurrently taking hydrochlorothiazide, desmopressin, sulbactam-ampicillin, carbazochrome, ranitidine and/or nitroglycerin for the duration of the surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tranexamic Acid
Intra-articular administration of low dose Tranexamic acid
Drug: Tranexamic Acid
0.5g Tranexamic Acid in 0.9% Sodium Chloride (study group) will be injected into the joint after final closure through a temporary catheter that is brought out through the incision.
Other Names:
  • DIN#: 02246365, Sandoz Canada Inc.
Placebo Comparator: Placebo
Sodium Chloride
Other: Placebo
0.9% Sodium Chloride (placebo group) will be injected into the joint after final closure through a temporary catheter that is brought out through the incision.
Other Names:
  • Sodium Chloride solution

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from Baseline in hemoglobin during hospital stay
Time Frame: routinely measured post-op day 1 and 3
routinely measured post-op day 1 and 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Serum Troponin
Time Frame: Every 6 hours for 24 hours post-op
Every 6 hours for 24 hours post-op
D-dimer
Time Frame: Post-op day 1 and 2
Post-op day 1 and 2

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Post-operative blood transfusion
Time Frame: During the first 7 days
documentation of blood transfusion post-operative
During the first 7 days
Major or minor bleeding events
Time Frame: within 90 days of surgery
within 90 days of surgery
Self-reported visual disturbances
Time Frame: within 90 days of surgery
within 90 days of surgery
Self-reported symptomatic DVT
Time Frame: within 90 days of surgery
within 90 days of surgery
Self-reported PE
Time Frame: within 90 days of surgery
within 90 days of surgery
Self-reported stroke
Time Frame: within 90 days of surgery
within 90 days of surgery
Death
Time Frame: within 90 days of surgery
within 90 days of surgery
Intra-operative fluid balance
Time Frame: during surgery
documentation of the volume of saline fluid via intravenous given to patients
during surgery
Bleeding sources other than the knee or hip (eg: GI bleed)
Time Frame: within 90 days of surgery
within 90 days of surgery
post-operative fluid balance
Time Frame: within 3- 5 days of surgery
documentation of the volume of saline fluid via intravenous given to patients
within 3- 5 days of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Orthopaedic Innovation Centre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas R Turgeon, MD, Concordia Joint Replacement Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 21, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B2013-089

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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