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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02393963
• Other study ID #: B2013-089
• Status: Completed
• Phase: Phase 2
• First received: March 3, 2015
• Last updated: April 6, 2017
• Start date: July 2015
• Est. completion date: December 21, 2016

Study information

• Verified date: September 2016
• Source: Orthopaedic Innovation Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 21, 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
Canada	Concordia Hospital	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Orthopaedic Innovation Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post-operative blood transfusion	documentation of blood transfusion post-operative	During the first 7 days
Other	Major or minor bleeding events		within 90 days of surgery
Other	Self-reported visual disturbances		within 90 days of surgery
Other	Self-reported symptomatic DVT		within 90 days of surgery
Other	Self-reported PE		within 90 days of surgery
Other	Self-reported stroke		within 90 days of surgery
Other	Death		within 90 days of surgery
Other	Intra-operative fluid balance	documentation of the volume of saline fluid via intravenous given to patients	during surgery
Other	Bleeding sources other than the knee or hip (eg: GI bleed)		within 90 days of surgery
Other	post-operative fluid balance	documentation of the volume of saline fluid via intravenous given to patients	within 3- 5 days of surgery
Primary	Change from Baseline in hemoglobin during hospital stay		routinely measured post-op day 1 and 3
Secondary	Serum Troponin		Every 6 hours for 24 hours post-op
Secondary	D-dimer		Post-op day 1 and 2