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.
Not Applicable
- Conditions
- Health Condition 1: null- Patients with Osteoarthritis knee
- Registration Number
- CTRI/2015/09/006185
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
Patients diagnosed with osteoarthritis scheduled for unilateral cemented TKA, either sex, aged <80 years
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Requirement of blood transfusion , safetyTimepoint: Course of inpatient stay after total knee arthroplasty and follow up for 3 months