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

Phase 4

Completed

Conditions: Osteoarthritis

Interventions: Drug: Evicel fibrin sealant

Registration Number: NCT01235715

Lead Sponsor: Hospital for Special Surgery, New York

Brief Summary: 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: No additional data desired

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 200

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Evicel	Evicel fibrin sealant	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.

Primary Outcome Measures

Name	Time	Method
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	24 hours post-operatively	A measurement of the amount of blood drained from the knee.
Number of Autologous Transfusion Units Over the Course of the Hospital Stay	perioperatively	Units of autologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.
Units of Homologous Transfusion Over the Course of the Hospital Stay	three days postoperatively	Units of homologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.

Secondary Outcome Measures

Name	Time	Method
Visual Analog Pain Scale (At Night) At 6 Weeks	6 weeks postoperatively	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.
Change in International Normalized Ratio (INR) Level on Day 2 Compared to Preoperatively	preoperatively and two days after surgery	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.
Range of Motion on Day 3	3 days postoperatively	A measurement of the degrees of motion of the operated knee three days after surgery.
Visual Analog Pain Scale on Day 3	3 days postoperatively	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.
Range of Motion at 6 Weeks	6 weeks postoperatively	A measurement of the degrees of motion of the operated knee six weeks after surgery.
Visual Analog Pain Scale (at Rest) at 6 Weeks	6 weeks postoperatively	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.
Visual Analog Pain Scale (During Activity) at 6 Weeks	6 weeks postoperatively	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.
Visual Analog Pain Scale (During Therapy) at 6 Weeks	6 weeks postoperatively	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.