The Use of Fibrin Sealant to Reduce Bleeding After Total Knee Replacement
Overview
- Phase
- Not Applicable
- Intervention
- Evicel
- Conditions
- Total Knee Replacement
- Sponsor
- University of Milan
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Fall in post-operative hemoglobin level after total knee replacement
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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) in patient undergoing total knee replacement (TKR) reduce the perioperative blood loss and the need for allogenic blood transfusion compared to a control group. We hypothesize that fibrin sealant decrease the drop in post-operative hemoglobin level after total knee replacement.
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 replacement (TKR) with an incidence from 10% to 58%.Methods to prevent the need for allogenic blood transfusion after TKR include hemodilution, perioperative blood salvage and reinfusion, hypotensive anesthesia, preoperative autologous blood donation and intravenous administration of tranexamic acid. In the last decade, the topical use of fibrin sealant has become a logical surgical stratagem for reducing blood loss in total knee arthroplasty.Fibrin sealants mimic the final step of the coagulation cascade reducing blood loss and transfusion requirements. A novel hemostatic agent derived from banked allogenic human plasma (EVICEL, Johnson \& Johnson Wound Management, Ethicon, Somerville, NJ) is recently available on the market for a variety of surgical specialty. A randomized controlled study is conducted to test if the post-operative reduction in hemoglobin level would be lower in the fibrin sealant group compared to a control group.
Investigators
Pietro Randelli, MD
MD
University of Milan
Eligibility Criteria
Inclusion Criteria
- •patient scheduled for TKR
- •written informed consent
- •diagnosis of osteoarthritis
Exclusion Criteria
- •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
Arms & Interventions
Evicel
Intervention: Evicel
Outcomes
Primary Outcomes
Fall in post-operative hemoglobin level after total knee replacement
Time Frame: First 7 days after surgery
Hemoglobin values are collected in patients in first week post surgery to assess how these values have changed.
Secondary Outcomes
- total blood loss(until 7 day after surgery)
- Blood Transfusion rate(until 1 week after Surgery)