Back to resultsThe Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Evicel fibrin sealant
Sponsored by
About this trial
This is an interventional prevention trial for Osteoarthritis focused on measuring osteoarthritis, total knee replacement
Eligibility Criteria
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.
Sites / Locations
- Hospital for Special Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Evicel
no evicel
Arm Description
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.
Patients will receive standard treatment for bleeding as practiced at the Hospital for Special Surgery.
Outcomes
Primary Outcome Measures
Change in Hemoglobin on Day 0 Compared to Preoperatively
Change in Hematocrit on Day 0 Compared to Preoperatively
Change in Hemoglobin On Day 1 Compared to Preoperatively
Change in Hematocrit on Day 1 Compared to Preoperatively
Change in Hemoglobin on Day 2 Compared to Preoperatively
Change in Hematocrit on Day 2 Compared to Preoperatively
Drain Output
A measurement of the amount of blood drained from the knee.
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.
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.
Secondary Outcome Measures
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.
Range of Motion on Day 3
A measurement of the degrees of motion of the operated knee three days after surgery.
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.
Range of Motion at 6 Weeks
A measurement of the degrees of motion of the operated knee six weeks after surgery.
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.
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.
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.
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.
Full Information
NCT ID
NCT01235715
First Posted
October 8, 2010
Last Updated
August 22, 2013
Sponsor
Hospital for Special Surgery, New York
Collaborators
Ethicon, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01235715
Brief Title
The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery
Official Title
The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York
Collaborators
Ethicon, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
osteoarthritis, total knee replacement
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Evicel
Arm Type
Active Comparator
Arm Description
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.
Arm Title
no evicel
Arm Type
No Intervention
Arm Description
Patients will receive standard treatment for bleeding as practiced at the Hospital for Special Surgery.
Intervention Type
Drug
Intervention Name(s)
Evicel fibrin sealant
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Hemoglobin on Day 0 Compared to Preoperatively
Time Frame
preoperatively and on the day of surgery
Title
Change in Hematocrit on Day 0 Compared to Preoperatively
Time Frame
preoperatively and day of surgery
Title
Change in Hemoglobin On Day 1 Compared to Preoperatively
Time Frame
preoperatively and one day after surgery
Title
Change in Hematocrit on Day 1 Compared to Preoperatively
Time Frame
preoperatively and one day after surgery
Title
Change in Hemoglobin on Day 2 Compared to Preoperatively
Time Frame
preoperatively and two days after surgery
Title
Change in Hematocrit on Day 2 Compared to Preoperatively
Time Frame
preoperatively and two days after surgery
Title
Drain Output
Description
A measurement of the amount of blood drained from the knee.
Time Frame
24 hours post-operatively
Title
Number of Autologous Transfusion Units Over the Course of the Hospital Stay
Description
Units of autologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.
Time Frame
perioperatively
Title
Units of Homologous Transfusion Over the Course of the Hospital Stay
Description
Units of homologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.
Time Frame
three days postoperatively
Secondary Outcome Measure Information:
Title
Change in International Normalized Ratio (INR) Level on Day 2 Compared to Preoperatively
Description
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.
Time Frame
preoperatively and two days after surgery
Title
Range of Motion on Day 3
Description
A measurement of the degrees of motion of the operated knee three days after surgery.
Time Frame
3 days postoperatively
Title
Visual Analog Pain Scale on Day 3
Description
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.
Time Frame
3 days postoperatively
Title
Range of Motion at 6 Weeks
Description
A measurement of the degrees of motion of the operated knee six weeks after surgery.
Time Frame
6 weeks postoperatively
Title
Visual Analog Pain Scale (at Rest) at 6 Weeks
Description
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.
Time Frame
6 weeks postoperatively
Title
Visual Analog Pain Scale (During Activity) at 6 Weeks
Description
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.
Time Frame
6 weeks postoperatively
Title
Visual Analog Pain Scale (During Therapy) at 6 Weeks
Description
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.
Time Frame
6 weeks postoperatively
Title
Visual Analog Pain Scale (At Night) At 6 Weeks
Description
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.
Time Frame
6 weeks postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark P Figgie, M.D
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery
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