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

Primary Purpose

Osteoarthritis

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Tranexamic Acid

Placebo

About this trial

This is an interventional prevention trial for Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Concordia Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tranexamic Acid

Placebo

Arm Description

Intra-articular administration of low dose Tranexamic acid

Sodium Chloride

Outcomes

Primary Outcome Measures

Change from Baseline in hemoglobin during hospital stay

Secondary Outcome Measures

Serum Troponin

D-dimer

Full Information

NCT ID

NCT02393963

First Posted

March 3, 2015

Last Updated

April 6, 2017

Sponsor

Orthopaedic Innovation Centre

1. Study Identification

Unique Protocol Identification Number

NCT02393963

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

July 2015 (Actual)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

December 21, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Orthopaedic Innovation Centre

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tranexamic Acid

Arm Type

Experimental

Arm Description

Intra-articular administration of low dose Tranexamic acid

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Sodium Chloride

Intervention Type

Drug

Intervention Name(s)

Tranexamic Acid

Other Intervention Name(s)

DIN#: 02246365, Sandoz Canada Inc.

Intervention 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.

Intervention Type

Other

Intervention Name(s)

Placebo

Other Intervention Name(s)

Sodium Chloride solution

Intervention 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.

Primary Outcome Measure Information:

Title

Change from Baseline in hemoglobin during hospital stay

Time Frame

routinely measured post-op day 1 and 3

Secondary Outcome Measure Information:

Title

Serum Troponin

Time Frame

Every 6 hours for 24 hours post-op

Title

D-dimer

Time Frame

Post-op day 1 and 2

Other Pre-specified Outcome Measures:

Title

Post-operative blood transfusion

Description

documentation of blood transfusion post-operative

Time Frame

During the first 7 days

Title

Major or minor bleeding events

Time Frame

within 90 days of surgery

Title

Self-reported visual disturbances

Time Frame

within 90 days of surgery

Title

Self-reported symptomatic DVT

Time Frame

within 90 days of surgery

Title

Self-reported PE

Time Frame

within 90 days of surgery

Title

Self-reported stroke

Time Frame

within 90 days of surgery

Title

Death

Time Frame

within 90 days of surgery

Title

Intra-operative fluid balance

Description

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

Time Frame

during surgery

Title

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

Time Frame

within 90 days of surgery

Title

post-operative fluid balance

Description

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

Time Frame

within 3- 5 days of surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas R Turgeon, MD

Organizational Affiliation

Concordia Joint Replacement Group

Official's Role

Principal Investigator

Facility Information:

Facility Name

Concordia Hospital

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R2K 3S8

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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