The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery

Study Overview
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Brief Summary
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Application of Evicel hemostatic matrix during operation for unilateral total knee replacement surgery (TKA) will result in decreased bleeding and postoperative drain output, a reduction in transfusion requirements, and less reduction of hemoglobin.

Detailed Description
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No additional data desired

Official Title
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The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: Evicel fibrin sealant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Diagnosis of degenerative joint disease of the knee in patients medically suitable to undergo unilateral total knee arthroplasty Exclusion Criteria: Known allergies to human blood products. History of bleeding disorders. Patients with previous arthrotomy, however, with exception of medial or lateral menisectomy. Patients taking Lovenox, Plavix, Aggrenox or erythropoetin. (coumadin is acceptable) Additionally, any patient with an intra-operative complication (i.e bone fracture, vascular injury) or post-operative complication that would affect bleeding tendency will be excluded although data will be recorded for later analysis. Also, any patient who has a complication with the suction drain (eg inadvertently being pulled out, suction failing) will have the remaining data points recorded and drain measurements will be excluded from analysis.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Evicel<br>Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent. | Drug: Evicel fibrin sealant<br>* Used for hemostasis to control bleeding. It has been shown to stop bleeding in 2 minutes or less. It is a combination of a biologic activated component containing human fibrinogen and topical thrombin functioning on wet, actively bleeding tissue.<br>|
| No Intervention: no evicel<br>Patients will receive standard treatment for bleeding as practiced at the Hospital for Special Surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin on Day 0 Compared to Preoperatively |  | preoperatively and on the day of surgery | 
| Change in Hematocrit on Day 0 Compared to Preoperatively |  | preoperatively and day of surgery | 
| Change in Hemoglobin On Day 1 Compared to Preoperatively |  | preoperatively and one day after surgery | 
| Change in Hematocrit on Day 1 Compared to Preoperatively |  | preoperatively and one day after surgery | 
| Change in Hemoglobin on Day 2 Compared to Preoperatively |  | preoperatively and two days after surgery | 
| Change in Hematocrit on Day 2 Compared to Preoperatively |  | preoperatively and two days after surgery | 
| Drain Output | A measurement of the amount of blood drained from the knee. | 24 hours post-operatively | 
| Number of Autologous Transfusion Units Over the Course of the Hospital Stay | Units of autologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded. | perioperatively | 
| Units of Homologous Transfusion Over the Course of the Hospital Stay | Units of homologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded. | three days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in International Normalized Ratio (INR) Level on Day 2 Compared to Preoperatively | The INR, a measure of the clotting tendency of blood, is a ratio of a patient's prothrombin time (the time a blood plasma takes to clot after the addition of tissue factor) to a normal prothrombin time. | preoperatively and two days after surgery | 
| Range of Motion on Day 3 | A measurement of the degrees of motion of the operated knee three days after surgery. | 3 days postoperatively | 
| Visual Analog Pain Scale on Day 3 | The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. | 3 days postoperatively | 
| Range of Motion at 6 Weeks | A measurement of the degrees of motion of the operated knee six weeks after surgery. | 6 weeks postoperatively | 
| Visual Analog Pain Scale (at Rest) at 6 Weeks | The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain at rest, the patient indicates their level of pain while seated or lying down, not moving. | 6 weeks postoperatively | 
| Visual Analog Pain Scale (During Activity) at 6 Weeks | The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain during, the patient indicates their level of pain while doing activities of daily living such as walking and moving from sitting to standing. | 6 weeks postoperatively | 
| Visual Analog Pain Scale (During Therapy) at 6 Weeks | The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain during, the patient indicates their level of pain during physical therapy. | 6 weeks postoperatively | 
| Visual Analog Pain Scale (At Night) At 6 Weeks | The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain at night, the patient indicates their level of pain during or before sleep. | 6 weeks postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, total knee replacement