Status:
COMPLETED
The Use of Fibrin Sealant to Reduce Bleeding After Total Knee Replacement
Lead Sponsor:
University of Milan
Conditions:
Total Knee Replacement
Primary Knee Arthroplasty
Eligibility:
All Genders
Phase:
NA
Brief Summary
A randomized controlled study is performed to address the question of whether the topical application of a novel fibrin sealant, Evicel (Johnson \& Johnson Wound Management, Ethicon, Somerville, NJ) i...
Detailed Description
Total knee replacement is an invasive surgical procedure that can expose patients to massive perioperative bleeding. This hematic loss results in a high rate of blood transfusion after total knee repl...
Eligibility Criteria
Inclusion
- patient scheduled for TKR
- written informed consent
- diagnosis of osteoarthritis
Exclusion
- previous intervention on the same Knee (except for meniscectomy)
- Hb pre-operative level lower than 12g/dl for man and 11g/dl for woman
- Anticoagulation therapy or any anti-aggregate treatment not suspended at least 4 days before surgery
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01816282
Start Date
March 1 2011
End Date
June 1 2012
Last Update
March 25 2013
Active Locations (1)
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1
Unità Operativa Ortopedia e Traumatologia II Policlinico San Donato
San Donato Milanese, Milano, Italy