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How intravenous tranexamic acid affects blood loss and recovery in total knee replacement surgery

The effect of intravenous tranexamic acid on perioperative blood loss, transfusion requirements, verticalization, and ambulation in total knee arthroplasty: a randomized double-blind study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN51057468
Enrollment
100
Registered
2024-06-04
Start date
2012-10-20
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Reducing perioperative blood loss in patients undergoing primary unilateral total knee arthroplasty Surgery

Interventions

This trial has been designed to determine the efficacy of tranexamic acid (TXA) in reducing perioperative blood loss in patients undergoing primary unilateral total knee arthroplasty (TKA). The study'

Sponsors

Klinicki centar Vojvodine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adult female and male patients who plan to undergo primary, unilateral TKA due to degenerative knee diseases 2. ASA status 1-3 3. Provide written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: 1. Patients with a known allergy to TXA 2. Coagulation disorders 3. Previous history of any type of thromboembolic event 4. Those who received fresh frozen plasma, other blood products, or drugs affecting the coagulation system 24 hours before surgery 5. Severe heart disease (New York Heart Association Classification-NYHA III and IV), creatinine values above115 µmol/l for men and 100 µmol/l for women, elevated liver enzymes, or congenital thrombophilia

Design outcomes

Primary

MeasureTime frame
Efficacy of tranexamic acid on perioperative blood loss measured using intraoperative and postoperative blood loss. The intraoperative loss was estimated by visually examining graduated suction canisters, expressed in ml, and gauze/sponges loss was determined using the gravimetric method. The postoperative blood loss was measured after 6, 12, and 24 hours, including drain loss measured in ml and total postoperative loss from 0-24 hours. Perioperative blood loss is calculated as intraoperative plus postoperative blood loss in ml.

Secondary

MeasureTime frame
1. Need for transfusion is calculated as the total number of allogenic blood units given intraoperatively up to 48 hrs postoperatively 2. Verticalisation and ambulation of patients were measured as the first time to verticalisation (standing up with no help) and the first time to ambulation (walking with the help of crutches)

Countries

Serbia

Contacts

Public ContactArsen Uvelin
arsen.uvelin@mf.uns.ac.rs+381642750276

Outcome results

None listed

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