An interventional study of Evicel in Total Knee Replacement, Primary Knee Arthroplasty and Osteoarthritis of the Knee, sponsored by University of Milan. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2013-03-25.
Sponsored by University of Milan · Not applicable, Interventional, and Treatment
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.
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.
3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.
This study's enrollment of 62 is below the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →University of Milan is the lead sponsor of 177 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
Drug: Evicel
Evicel (5ml) is sprayed over the soft tissue after the implant of prosthetic components and before wounding closure
Fall in post-operative hemoglobin level after total knee replacement
Hemoglobin values are collected in patients in first week post surgery to assess how these values have changed.
Time frame: First 7 days after surgery
total blood loss
Calculation of perioperative blood loss is based on changes in hemoglobin (Hb) level. Assuming that the blood volume V0 on the seventh day after surgery is the same as that before surgery the loss of Hb is estimated according to the following formula: Hb-loss (g) =V0 (l)×(Hbpre-op (g/l)-Hb7day post-op(g/l))+Hb-transfused (g) where: * Hb-loss (g) is the amount of hemoglobin lost * Hbpre-op (g/l) is the hemoglobin level before surgery * Hb7day post-op (g/l) is the hemoglobin level in postoperative day 7 * Hb-transfused (g) is the total amount of allogeneic hemoglobin transfused; a unit of banked blood is considered to contain 52 g of hemoglobin. * V0 (l) is the total blood volume of patient and it is calculated using the formula of Nadler: V0male(l)=0.3669×height(m)3+0.03219×weight(Kg)+0.6041 V0female(l)=0.3561×height(m)3+0.0338×weight(Kg)+0.1833 The total blood loss is calculated as follows: Blood loss(l)=Hb-loss(g)/Hbpre-op(g/l)
Time frame: until 7 day after surgery
Blood Transfusion rate
Number of patients requiring 1 or more unit of allogenic banked blood
Time frame: until 1 week after Surgery
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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University of Milan