Trial intelligence / Profile preview

Optimal Dose of Tranexamic Acid in Total Joint Arthroplasty

NCT02584725Phase 4

Key facts

Status: Completed
Start: Dec 2014
Primary completion: Jun 2015
Sponsor: Columbia University
Modality: Small Molecules

Drugs: tranexamic acid
Conditions: Arthropathy of HipArthropathy Of Knee

Overview

Phase 4, randomised, double-blind trial of tranexamic acid in Arthropathy of Hip and Arthropathy Of Knee, sponsored by Columbia University. Primary endpoint: Change in Hemoglobin From Baseline to the First Post-operative Day (POD#1) at 1 day. Started Dec 2014; status: completed.

Design

Study design: RandomizedDouble-blind

Who it enrols

Patients undergoing primary unilateral total knee or hip arthroplasty under spinal anesthesia. Excludes patients >100kg, baseline Hb <10, history of coagulopathy, recent thromboembolic events or PCI, or anticoagulant use.

Endpoints

Primary

Change in Hemoglobin From Baseline to the First Post-operative Day (POD#1)1 day

Secondary

Change in Hemoglobin From Baseline to POD#0 and POD#22 days
Number of Participants Requiring Blood Transfusion From the Intra-operative Period Into the End of POD#22 days
Total Estimated Intra-operative Blood Loss2 hours
Volume of Blood in the Surgical Suction Canister at the End of Surgery2 hours
Count of Participants Able to Sit, Stand, and Walk on POD1 and POD22 days
Visual Analog Scale (VAS) Pain Scores on POD#1 and POD#22 days
Wellbeing Questionnaire Score on POD#1 and POD#22 days
Count of Seizure, Transient Ischemic Attack, Stroke, Myocardial Infarction, Deep Venous Thrombosis, and Pulmonary Embolus2 days

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