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Completed

NCT Number: NCT02393963

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Concordia Hospital

Winnipeg, Manitoba, R2K 3S8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tranexamic Acid

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.

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

Placebo

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.

Other names: Sodium Chloride solution

Primary outcomes

  1. Change from Baseline in hemoglobin during hospital stay

    Time frame: routinely measured post-op day 1 and 3

Secondary outcomes

  1. Serum Troponin

    Time frame: Every 6 hours for 24 hours post-op

  2. D-dimer

    Time frame: Post-op day 1 and 2

Other outcomes

  1. Post-operative blood transfusion

    Time frame: During the first 7 days

    documentation of blood transfusion post-operative

  2. Major or minor bleeding events

    Time frame: within 90 days of surgery

  3. Self-reported visual disturbances

    Time frame: within 90 days of surgery

  4. Self-reported symptomatic DVT

    Time frame: within 90 days of surgery

  5. Self-reported PE

    Time frame: within 90 days of surgery

  6. Self-reported stroke

    Time frame: within 90 days of surgery

  7. Death

    Time frame: within 90 days of surgery

  8. Intra-operative fluid balance

    Time frame: during surgery

    documentation of the volume of saline fluid via intravenous given to patients

  9. Bleeding sources other than the knee or hip (eg: GI bleed)

    Time frame: within 90 days of surgery

  10. post-operative fluid balance

    Time frame: within 3- 5 days of surgery

    documentation of the volume of saline fluid via intravenous given to patients

Sponsors and collaborators

Lead sponsor

Orthopaedic Innovation Centre

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 20, 2015
Registry last updated
Apr 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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