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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Drug: Evicel fibrin sealant

Detailed Description

No additional data desired

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Evicel; 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; 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.
NO_INTERVENTION: no evicel; Patients will receive standard treatment for bleeding as practiced at the Hospital for Special Surgery.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Collaborators: Ethicon, Inc.
• Investigators: Principal Investigator: Mark P Figgie, M.D, Hospital for Special Surgery, New York

Publications and helpful links

Helpful Links

• Ethicon website

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (ACTUAL): March 1, 2012
• Study Completion (ACTUAL): September 1, 2012

Study Registration Dates

• First Submitted: October 8, 2010
• First Submitted That Met QC Criteria: November 4, 2010
• First Posted (ESTIMATE): November 5, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): October 29, 2013
• Last Update Submitted That Met QC Criteria: August 22, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: osteoarthritis; total knee replacement
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Hemostatics; Coagulants; Fibrin Tissue Adhesive
• Other Study ID Numbers: 29054