Overview

Tranexamic Acid Dosing for Major Joint Replacement Surgery

Status:
Not yet recruiting

Trial end date:
2023-08-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Sunnybrook Health Sciences Centre

Treatments:

Tranexamic Acid

Criteria

Inclusion Criteria

1. Adults > 18 years of age

2. Elective unilateral hip or knee joint replacement

Exclusion Criteria

1. Contraindication to TXA (e.g., allergy, thrombophilia, tretinoin)

2. Advanced liver disease (>2-fold rise in liver enzymes, as this may alter PK analysis)

3. Anti-coagulant use within the last 1-4 days prior (depends on anticoagulant, prior to
the day of surgery)