Status:
COMPLETED
Efficacy Comparison of Topical and Intravenous Tranexamic Acid to Reduce the Number of Blood Transfusions in TKA
Lead Sponsor:
Hospital Universitario La Paz
Conditions:
Blood Loss
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The main objective is to evaluate the efficacy and safety of topical Tranexamic Acid (TA) to reduce the blood transfusion rate in total knee arthroplasty. The secondary endpoints are to estimate the v...
Detailed Description
The groups will be compared by ITT and PP. The non-inferiority would be estimated by comparing the confidence interval using the traditional test, and Wilson test.
Eligibility Criteria
Inclusion
- Adult patients (greater than 18 years old)
- Patients scheduled for primary unilateral knee arthroplasty
- Patients for La Paz- Cantoblanco Hospital, Madrid, Spain
Exclusion
- Patients that refuse to sign the Inform Consent
- Allergy to tranexamic acid
- Major comorbidities: Severe ischemic heart disease(class III and IV of New York Heart Association); sleep apnea syndrome; severe EPOC; renal dysfunction (plasma creatinine\>2mg/dL if mens and \>1.8mg/dL if woman); or hepatic disfunction.
- Coagulopathy (preoperative platelet count \<150,000/mm3, INR\>1.4, prolonged PPT(\>1.4 x normal)
- History of thromboembolic disease: CVA, DVT, PE
- Blood dyscrasias
- Retinopathy (disturbances of color vision)
- Jehovah's witnesses
- Pregnancy
- Breastfeeding
- Been participating or been participated a year ago in another clinical trial
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT01881568
Start Date
January 1 2013
End Date
January 1 2014
Last Update
December 3 2014
Active Locations (1)
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1
Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046