NCT02393963

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 20, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2016

Completed
Last Updated

April 10, 2017

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

March 3, 2015

Last Update Submit

April 6, 2017

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in hemoglobin during hospital stay

    routinely measured post-op day 1 and 3

Secondary Outcomes (2)

  • Serum Troponin

    Every 6 hours for 24 hours post-op

  • D-dimer

    Post-op day 1 and 2

Other Outcomes (10)

  • Post-operative blood transfusion

    During the first 7 days

  • Major or minor bleeding events

    within 90 days of surgery

  • Self-reported visual disturbances

    within 90 days of surgery

  • +7 more other outcomes

Study Arms (2)

Tranexamic Acid

EXPERIMENTAL

Intra-articular administration of low dose Tranexamic acid

Drug: Tranexamic Acid

Placebo

PLACEBO COMPARATOR

Sodium Chloride

Other: Placebo

Interventions

Tranexamic AcidDRUG

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.

Also known as: DIN#: 02246365, Sandoz Canada Inc.
Tranexamic Acid
PlaceboOTHER

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.

Also known as: Sodium Chloride solution
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Concordia Hospital

Winnipeg, Manitoba, R2K 3S8, Canada

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Tranexamic AcidSodium Chloride

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Thomas R Turgeon, MD

    Concordia Joint Replacement Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2015

First Posted

March 20, 2015

Study Start

July 1, 2015

Primary Completion

July 1, 2016

Study Completion

December 21, 2016

Last Updated

April 10, 2017

Record last verified: 2016-09

Locations

CA(1)