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

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

Sponsors

Lead Sponsor: Orthopaedic Innovation Centre

Source Orthopaedic Innovation Centre
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.

Overall Status Completed
Start Date July 2015
Completion Date December 21, 2016
Primary Completion Date July 2016
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change from Baseline in hemoglobin during hospital stay routinely measured post-op day 1 and 3
Secondary Outcome
Measure Time Frame
Serum Troponin Every 6 hours for 24 hours post-op
D-dimer Post-op day 1 and 2
Enrollment 140
Condition
Intervention

Intervention Type: Drug

Intervention Name: Tranexamic Acid

Description: 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.

Arm Group Label: Tranexamic Acid

Other Name: DIN#: 02246365, Sandoz Canada Inc.

Intervention Type: Other

Intervention Name: Placebo

Description: 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.

Arm Group Label: Placebo

Other Name: 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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Thomas R Turgeon, MD Principal Investigator Concordia Joint Replacement Group
Location
Facility: Concordia Hospital
Location Countries

Canada

Verification Date

September 2016

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Tranexamic Acid

Type: Experimental

Description: Intra-articular administration of low dose Tranexamic acid

Label: Placebo

Type: Placebo Comparator

Description: Sodium Chloride

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov