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

• ClinicalTrials.gov Identifier: NCT01235715
• Recruitment Status: Completed
• First Posted: November 5, 2010
• Results First Posted: October 29, 2013
• Last Update Posted: October 29, 2013
• Sponsor: Hospital for Special Surgery, New York
• Collaborator: Ethicon, Inc.
• Information provided by (Responsible Party): Hospital for Special Surgery, New York

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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis	Drug: Evicel fibrin sealant	Phase 4

Detailed Description:

No additional data desired

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery
• Study Start Date: September 2010
• Actual Primary Completion Date: March 2012
• Actual Study Completion Date: September 2012

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

1. Change in International Normalized Ratio (INR) Level on Day 2 Compared to Preoperatively [ Time Frame: 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.
2. Range of Motion on Day 3 [ Time Frame: 3 days postoperatively ]
   A measurement of the degrees of motion of the operated knee three days after surgery.
3. Visual Analog Pain Scale on Day 3 [ Time Frame: 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.
4. Range of Motion at 6 Weeks [ Time Frame: 6 weeks postoperatively ]
   A measurement of the degrees of motion of the operated knee six weeks after surgery.
5. Visual Analog Pain Scale (at Rest) at 6 Weeks [ Time Frame: 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.
6. Visual Analog Pain Scale (During Activity) at 6 Weeks [ Time Frame: 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.
7. Visual Analog Pain Scale (During Therapy) at 6 Weeks [ Time Frame: 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.
8. Visual Analog Pain Scale (At Night) At 6 Weeks [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, New York

Hospital for Special Surgery

New York, New York, United States, 10021

Sponsors and Collaborators

Hospital for Special Surgery, New York

Ethicon, Inc.

Investigators

• Principal Investigator: Mark P Figgie, M.D; Hospital for Special Surgery, New York

More Information

• Responsible Party: Hospital for Special Surgery, New York
• ClinicalTrials.gov Identifier: NCT01235715
• Other Study ID Numbers: 29054
• First Posted: November 5, 2010
• Results First Posted: October 29, 2013
• Last Update Posted: October 29, 2013
• Last Verified: August 2013

Keywords provided by Hospital for Special Surgery, New York:

osteoarthritis; total knee replacement

Additional relevant MeSH terms:

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Fibrin Tissue Adhesive; Hemostatics; Coagulants