Skip to content

PROSPECTIVE RANDOMIZED DOUBLE-BLINDED PLACEBO CONTROLLED TRAIL STUDYING EFFICACY IN TERMS OF BLOOD LOSS AND SAFETY IN TERMS DVT OF INTRA-ARTICULAR TRANEXAMIC ACID IN UNILATERAL TOTAL KNEE ARTHROPLASTY.

EFFICACY AND SAFETY OF INTRA-ARTICULAR TRANEXAMIC ACID TO REDUCE POST OPERATIVE BLOOD LOSS AND TO MEASURE SAFETY IN UNILATERAL TOTAL KNEE ARTHROPLASTY.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/09/006185
Enrollment
50
Registered
2015-09-15
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: null- Patients with Osteoarthritis knee

Interventions

Intervention1: Administration of tranexamic acid (Antifibrinolytic): 1000mg/10ml single dose, intra-articular after wound closure of total knee arthroplasty and clamping of drain for an hour Control I

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients diagnosed with osteoarthritis scheduled for unilateral cemented TKA, either sex, aged <80 years

Exclusion criteria

Exclusion criteria: Revision TKR/ Bilateral TKR Known or suspected allergy to medication Inherited or acquired hemostatic disease Abnormal coagulation screening test(platelet count, prothrombin time, APTT) Ingestion of aspirin within seven days of surgery Renal / Hepatic insufficiency Pregnancy History of DVT or Pulmonary embolism History of ocular pathology or ophthalmological procedures other then corrective lenses History of haematuria

Design outcomes

Primary

MeasureTime frame
Blood Loss, measured by drain output drop in Hb and PCV,safety assessed by B/L lower limb dopplerTimepoint: Blood Loss, measured by drain output at 6hr,24hr, and 48hr post operatively, drop in Hb and PCV at post operative day 0,day 1,day 7 and day 14,no.of patient require blood transfusion,safety assessed by B/L lower limb doppler at 7th post operative day ,6th week and 3rd month.

Secondary

MeasureTime frame
Requirement of blood transfusion , safetyTimepoint: Course of inpatient stay after total knee arthroplasty and follow up for 3 months

Countries

India

Contacts

Public ContactDrCSYadav

AIIMS, New Delhi.

prashantb220785@gmail.com09013952790

Outcome results

None listed

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