Comparison of the effectiveness of tranexamic acid drug in simultaneous intravenous and joint administration compared to only joint administration in reducing bleeding after knee joint replacement surgery.

Evaluating efficacy and safety of topical and intravenous tranexamicacid for reducing peri/postoperative blood loss in primary Total knee arthroplasty

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220222054093N1

Enrollment

Registered

2022-09-24

Start date

2022-10-09

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

Reduction of bleeding during knee replacement surgery among subjects receiving intravenous and intra-articular tranexamic acid and subjects receiving intra-articular only.. total knee replacement

Interventions

Intervention group: First group: patients who receive a single dose of tranexamic acid intravenously before the start of the operation, and at the end of the operation, a single dose is injected intra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with severe knee osteoarthritis whose pain is not controlled by drug treatment and are candidates for joint replacement.

Exclusion criteria

Exclusion criteria: Patients who have contraindications to receive tranexamic acid

Design outcomes

Primary

Measure	Time frame
Determination of efficacy and safety of intra-articular and intravenous TXA in primary TKA. Timepoint: The intravenous group receives 15 mg per kilogram of the patient's weight intravenously, 5 minutes before the tourniquet is inflated, and 5 minutes after the completion of the skin suture and before the opening of the tourniquet, the same intravenous dose is injected again. The local group receives only 15 mg of tranexamic acid per kilogram of the patient's weight after the completion of the skin suture and 5 minutes before opening the tourniquet. The amount of hemoglobin after the operation is measured at intervals of 6 hours, 12 hours, 24 hours and 48 hours. In addition, the need for blood transfusion is also checked. Method of measurement: Laboratory test.	—

Measure

Time frame

Determination of efficacy and safety of intra-articular and intravenous TXA in primary TKA. Timepoint: The intravenous group receives 15 mg per kilogram of the patient's weight intravenously, 5 minutes before the tourniquet is inflated, and 5 minutes after the completion of the skin suture and before the opening of the tourniquet, the same intravenous dose is injected again. The local group receives only 15 mg of tranexamic acid per kilogram of the patient's weight after the completion of the skin suture and 5 minutes before opening the tourniquet. The amount of hemoglobin after the operation is measured at intervals of 6 hours, 12 hours, 24 hours and 48 hours. In addition, the need for blood transfusion is also checked. Method of measurement: Laboratory test.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr seyed Mehdi Hoseini

Shahid Beheshti University of Medical Sciences

smhaa303@gmail.com+98 21 2260 5090

Outcome results

None listed

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