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

This study has been completed.
Sponsor:
Collaborator:
Ethicon, Inc.
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT01235715
First received: October 8, 2010
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Osteoarthritis
Drug: Evicel fibrin sealant
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery

Resource links provided by NLM:


Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:
  • Change in Hemoglobin on Day 0 Compared to Preoperatively [ Time Frame: preoperatively and on the day of surgery ] [ Designated as safety issue: No ]
  • Change in Hematocrit on Day 0 Compared to Preoperatively [ Time Frame: preoperatively and day of surgery ] [ Designated as safety issue: No ]
  • Change in Hemoglobin On Day 1 Compared to Preoperatively [ Time Frame: preoperatively and one day after surgery ] [ Designated as safety issue: No ]
  • Change in Hematocrit on Day 1 Compared to Preoperatively [ Time Frame: preoperatively and one day after surgery ] [ Designated as safety issue: No ]
  • Change in Hemoglobin on Day 2 Compared to Preoperatively [ Time Frame: preoperatively and two days after surgery ] [ Designated as safety issue: No ]
  • Change in Hematocrit on Day 2 Compared to Preoperatively [ Time Frame: preoperatively and two days after surgery ] [ Designated as safety issue: No ]
  • Drain Output [ Time Frame: 24 hours post-operatively ] [ Designated as safety issue: No ]
    A measurement of the amount of blood drained from the knee.

  • Number of Autologous Transfusion Units Over the Course of the Hospital Stay [ Time Frame: perioperatively ] [ Designated as safety issue: No ]
    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 [ Time Frame: three days postoperatively ] [ Designated as safety issue: No ]
    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 [ Time Frame: preoperatively and two days after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 days postoperatively ] [ Designated as safety issue: No ]
    A measurement of the degrees of motion of the operated knee three days after surgery.

  • Visual Analog Pain Scale on Day 3 [ Time Frame: 3 days postoperatively ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks postoperatively ] [ Designated as safety issue: No ]
    A measurement of the degrees of motion of the operated knee six weeks after surgery.

  • Visual Analog Pain Scale (at Rest) at 6 Weeks [ Time Frame: 6 weeks postoperatively ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks postoperatively ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks postoperatively ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks postoperatively ] [ Designated as safety issue: No ]
    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.


Enrollment: 200
Study Start Date: September 2010
Study Completion Date: September 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

No additional data desired

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01235715

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

Additional Information:
No publications provided

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01235715     History of Changes
Other Study ID Numbers: 29054
Study First Received: October 8, 2010
Results First Received: January 31, 2013
Last Updated: August 22, 2013
Health Authority: United States: Institutional Review Board

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
Coagulants
Hematologic Agents
Hemostatics
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014