CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
Tranexamic aciddrug
Likely dose
Tranexamic acid 20 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05075200
NCT05075200Phase 2Completed

Tranexamic Acid Dosing for Major Joint Replacement Surgery

Sunnybrook Health Sciences Centre·interventional·Posted Oct 12, 2021·Updated Dec 9, 2025

In Brief

A Phase 2 clinical trial evaluating Tranexamic acid for Arthroplasty, Replacement, Knee and Arthroplasty, Replacement, Hip. Completed, enrolled 21 participants across 1 site.

Detailed Summary

Over 1.7 million hip and knee replacements are performed every year worldwide. These surgeries are associated with high blood loss and transfusion rates. In older patients, the high blood loss can result in postoperative anemia. Anemia is a condition where there is a lack of healthy red blood cells to carry oxygen around the body. This means, the patient may need a blood transfusion. This can result in different immune responses such as lung injury, fluid overload, and sepsis. The purpose of this study is to find an optimal dose of tranexamic acid (TXA) to be given during a hip or knee replacement surgery. TXA is one of the drugs given during surgery because it lowers the amount of bleeding and the risk of a blood transfusion. Individuals who are chosen to participate in the study will be split into two separate groups. After anesthesia is administered, study participant will be given the hospitals standard dose of TXA which is 20mg/kg. However, in patients with kidney problems and lower kidney functions, the dose will be lowered because TXA is filtered out of the body through the kidneys. Throughout the surgery and after it, patients will have about 30-50mL (3-5 tablespoons) of blood samples drawn at specific time points. This will be done through IV line which will stay in place during the surgery and post operation to minimize the amount of needle puncturing's. This study will help to development a new dosing guideline for TXA in patients who are undergoing joint replacement surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedOct 12, 2021
Enrollment StartDec 14, 2021
Primary CompletionOct 26, 2022
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.7 years ago

Interventions

Tranexamic aciddrug

Participants in both groups will be given single intravenous bolus of TXA 20 mg/kg over 15 min after induction of spinal (or other regional technique) or general anesthesia as per standard of care.