Tranexamic Acid in Total Knee Replacement

Democritus University of Thrace

Status: Completed

Conditions: Osteo Arthritis Knee

Treatments: Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03656445

546a - 26/10/2015

Details and patient eligibility

About

Multiple intravenous Tranexamic Acid doses can reduce postoperative blood loss and improve the functional outcome in total knee arthroplasty without tourniquet: a randomized controlled study.

Full description

A total of 180 patients undergoing TKA for knee osteoarthritis were stratified in three equal groups. All surgeries were performed under spinal anesthesia, without tourniquet and patients should be in agreement with the established inclusion/exclusion criteria. Group A (60 patients) received 1g of IV TXA, Group B (60 patients) received an additional dose of IV TXA and Group C (60 patients) received three doses of IV TXA. The measured outcomes were the Hemoglobin (Hb) decrease, the transfusion rate, the functional, quality of life (QoL) and pain assessment based on their corresponding scoring system.

Enrollment: 180 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. varus deformity less than 10o
2. lack of extension not more than 10o
3. flexion of at least 90o.

Exclusion criteria

1. uncontrolled medical diseases/comorbidities
2. allergy and/or hypersensitivity to TXA
3. a known history of thromboembolic disease, cardiovascular disease
4. coronary or vascular stent placed within the past 12 months
5. cerebral vascular disease (a history of stroke)
6. subarachnoid hemorrhage
7. preoperative coagulopathy (a platelet [PLT] count <150,000/mm3 or an international normalized ratio greater than 1.5
8. preoperative renal or hepatic dysfunction
9. retinal vein or artery occlusion
10. patients with anemia (<12 g/dL for female, <13 g/dL for male)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 3 patient groups

Group A - Tranexamic Acid

Active Comparator group

Description:

1 dose of IV TXA (15mg/kg) in 100-ml normal saline, 10 minutes before incision, administered during the induction of the anesthesia

Treatment:

Drug: Tranexamic Acid

Drug: Tranexamic Acid

Drug: Tranexamic Acid

Group B - Tranexamic Acid

Active Comparator group

Description:

1 dose of IV TXA (15mg/kg) in 100-ml normal saline, 10 minutes before incision and an additional dose of IV TXA (15mg/kg) in 100-ml normal saline 3 hours after skin incision

Treatment:

Drug: Tranexamic Acid

Drug: Tranexamic Acid

Drug: Tranexamic Acid

Group C - Tranexamic Acid

Active Comparator group

Description:

1 dose of IV TXA (15mg/kg) in 100-ml normal saline, before incision and two additional doses of IV TXA (15mg/kg) in 100-ml normal saline 3 and 6 hours after skin incision respectively

Treatment:

Drug: Tranexamic Acid

Drug: Tranexamic Acid

Drug: Tranexamic Acid