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

October 8, 2010
August 22, 2013
September 2010
March 2012   (final data collection date for primary outcome measure)
  • 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.
Fall in post-operative hemoglobin and hematocrit [ Time Frame: post operative day one and two ] [ Designated as safety issue: No ]
Hemoglobin and hematocrit values will be collected in patients on day one and two post surgery to assess how these values have changed. We hope this product will decrease the drop in these values. We also hope that there will be a decrease in post operative transfusions and that patients will have better clinical outcomes.
Complete list of historical versions of study NCT01235715 on ClinicalTrials.gov Archive Site
  • 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.
  • blood loss as measured by constavac drains [ Time Frame: 24 hours post insertion ] [ Designated as safety issue: No ]
    Patients will have two constavac drains inserted for 24 hours post surgery. The drain output will be measured at the end of the 24 hours. We hope this product will lead to less bleeding post operatively and therefore better clinical outcomes for patients.
  • Pain Scores on the Visual Analog Scale [ Time Frame: pre operatively through six week post operatively ] [ Designated as safety issue: No ]
    Patients's scale of pain using a visual analogue will be accessed pre operatively, post operatively through day 2 and at six week post operatively. We hypothesize this product will lead to less inflammation, pain and therefore better clinical outcomes.
  • The change in range of motion pre versus post operatively [ Time Frame: pre operatively through six weeks post operatively ] [ Designated as safety issue: No ]
    Patients passive range of motion will be recorded pre operatively, day 2 and at six weeks post operatively. We hope this product will decrease the time it takes for patients knee to return to standard range of motion
  • Anti-coagulation effects on bleeding [ Time Frame: pre operatively and post operative day 2 ] [ Designated as safety issue: No ]
    All patients will take coumadin for deep vein thrombosis prophylaxis as part of the standard of care for the two surgeons involved in this study. Because of this, we will record INR levels pre-operatively and on POD #2. This will act as an important control to ensure minimization of confounding effects of anti-coagulation on bleeding.
Not Provided
Not Provided
 
The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery
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.

No additional data desired

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Osteoarthritis
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.
  • 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.
    Intervention: Drug: Evicel fibrin sealant
  • No Intervention: no evicel
    Patients will receive standard treatment for bleeding as practiced at the Hospital for Special Surgery.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
September 2012
March 2012   (final data collection date for primary outcome measure)

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.
Both
20 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01235715
29054
No
Hospital for Special Surgery, New York
Hospital for Special Surgery, New York
Ethicon, Inc.
Principal Investigator: Mark P Figgie, M.D Hospital for Special Surgery, New York
Hospital for Special Surgery, New York
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP