Using tourniquet and IV tranexamic acid in unilateral Total Knee Arthroplasty (TKA) surgery

The effect of using tourniquet and IV tranexamic acid on clinical outcomes and blood loss in unilateral Total Knee Arthroplasty (TKA) surgery: a randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20221228056952N1

Enrollment

168

Registered

2023-12-30

Start date

2023-12-29

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Knee osteoarthritis. Condition 2: Unilateral total knee arthroplasty. Unilateral primary osteoarthritis of knee

Interventions

Intervention 1: Intervention group 1: 1000 mg of intravenous tranexamic acid 30 minutes prior to the incision plus 1000 mg of intravenous tranexamic acid during wound closure. Using tourniquet during

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients who refer to Ghaem hospital knee orthopedic clinic Indicated for unilateral total knee arthroplasty (TKA) surgery

Exclusion criteria

Exclusion criteria: allergy to TXA Active thromboembolic disease Seizure disorder Prior cerebrovascular accident Cardiac stents or a history of thromboembolic disease Prior renal disorder (glomerular filtration rate < 30 ml/min/1.73m2)

Design outcomes

Primary

Measure	Time frame
Blood loss volume. Timepoint: After surgery. Method of measurement: Postoperatively, blood loss will be calculated on the basis of the validated Gross formula, which includes sex, height, and weight, as well as pre-operative and postoperative day 2 hematocrit values with correction for any volume of blood administered.;Surgeon satisfaction with visualization during the procedure. Timepoint: After surgery. Method of measurement: Using a 10-point visualization scale, with 0 categorized as ‘‘poor’’ and 10 categorized as ‘‘good.’’ This will be completed by the operative surgeon at the end of the case.;Clinical outcomes. Timepoint: 2 and 6 months follow-up after surgery. Method of measurement: Pain score using Visual analogue scale (VAS), a 10-point visualization scale. Knee functional questionnaires of Oxford Knee Score, and WOMAC.	—

Measure

Time frame

Blood loss volume. Timepoint: After surgery. Method of measurement: Postoperatively, blood loss will be calculated on the basis of the validated Gross formula, which includes sex, height, and weight, as well as pre-operative and postoperative day 2 hematocrit values with correction for any volume of blood administered.;Surgeon satisfaction with visualization during the procedure. Timepoint: After surgery. Method of measurement: Using a 10-point visualization scale, with 0 categorized as ‘‘poor’’ and 10 categorized as ‘‘good.’’ This will be completed by the operative surgeon at the end of the case.;Clinical outcomes. Timepoint: 2 and 6 months follow-up after surgery. Method of measurement: Pain score using Visual analogue scale (VAS), a 10-point visualization scale. Knee functional questionnaires of Oxford Knee Score, and WOMAC.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohammad-Hossein Ebrahimzadeh

Mashhad University of Medical Sciences

Ebrahimzadehmh@mums.ac.ir+98 51 3801 2638

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026