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

NCT ID: NCT02393963

Last Updated: 2017-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-12-21

Brief Summary

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.

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Tranexamic Acid

Intra-articular administration of low dose Tranexamic acid

Group Type: EXPERIMENTAL

Tranexamic Acid

Intervention Type: DRUG

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.

Placebo

Sodium Chloride

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

DIN#: 02246365, Sandoz Canada Inc.; Sodium Chloride solution

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Orthopaedic Innovation Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas R Turgeon, MD

Role: PRINCIPAL_INVESTIGATOR

Concordia Joint Replacement Group

Locations

Concordia Hospital

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

B2013-089

Identifier Type: -

Identifier Source: org_study_id