Concordia Hospital
Winnipeg, Manitoba, R2K 3S8, Canada
NCT Number: NCT02393963
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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Notify Me18 year and older
All sexes
Interventional
Phase 2
Winnipeg, Manitoba, R2K 3S8, Canada
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
Time frame: routinely measured post-op day 1 and 3
Time frame: Every 6 hours for 24 hours post-op
Time frame: Post-op day 1 and 2
Time frame: During the first 7 days
documentation of blood transfusion post-operative
Time frame: within 90 days of surgery
Time frame: within 90 days of surgery
Time frame: within 90 days of surgery
Time frame: within 90 days of surgery
Time frame: within 90 days of surgery
Time frame: within 90 days of surgery
Time frame: during surgery
documentation of the volume of saline fluid via intravenous given to patients
Time frame: within 90 days of surgery
Time frame: within 3- 5 days of surgery
documentation of the volume of saline fluid via intravenous given to patients
Orthopaedic Innovation Centre
Other
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
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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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