The Use of Fibrin Sealant to Reduce Bleeding After Total Knee Replacement

Study 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.

Conditions
-----------------
Total Knee Replacement, Primary Knee Arthroplasty, Osteoarthritis of the Knee

Intervention / Treatment
-----------------
* Drug: Evicel


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evicel<br> | Drug: Evicel<br>* Evicel (5ml) is sprayed over the soft tissue after the implant of prosthetic components and before wounding closure<br>|
| No Intervention: Control<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | First 7 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | until 7 day after surgery | 
| Blood Transfusion rate | Number of patients requiring 1 or more unit of allogenic banked blood | until 1 week after Surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TKR, Blood loss, Fibrin Sealant