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
Results First Received: January 31, 2013  
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
Condition: Osteoarthritis
Intervention: Drug: Evicel fibrin sealant

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients undergoing total knee arthroplasty at the Hospital for Special Surgery from September 2010 to June 2012 were enrolled in a consecutive prospective manner on a voluntary basis.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.
No Evicel Patients will receive standard treatment for bleeding as practiced at HSS.

Participant Flow:   Overall Study
    Evicel     No Evicel  
STARTED     98     102  
COMPLETED     98     100  
NOT COMPLETED     0     2  
Physician Decision                 0                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
no Evicel Patients will receive standard treatment for bleeding as practiced at HSS.
Total Total of all reporting groups

Baseline Measures
    Evicel     no Evicel     Total  
Number of Participants  
[units: participants]
  98     102     200  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     34     41     75  
>=65 years     64     61     125  
Age  
[units: years]
Mean ± Standard Deviation
  68.12  ± 9.88     66.38  ± 8.47     67  ± 10  
Gender  
[units: participants]
     
Female     57     59     116  
Male     41     43     84  
Region of Enrollment  
[units: participants]
     
United States     98     102     200  



  Outcome Measures
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1.  Primary:   Change in Hemoglobin on Day 0 Compared to Preoperatively   [ Time Frame: preoperatively and on the day of surgery ]

2.  Primary:   Change in Hematocrit on Day 0 Compared to Preoperatively   [ Time Frame: preoperatively and day of surgery ]

3.  Primary:   Change in Hemoglobin On Day 1 Compared to Preoperatively   [ Time Frame: preoperatively and one day after surgery ]

4.  Primary:   Change in Hematocrit on Day 1 Compared to Preoperatively   [ Time Frame: preoperatively and one day after surgery ]

5.  Primary:   Change in Hemoglobin on Day 2 Compared to Preoperatively   [ Time Frame: preoperatively and two days after surgery ]

6.  Primary:   Change in Hematocrit on Day 2 Compared to Preoperatively   [ Time Frame: preoperatively and two days after surgery ]

7.  Primary:   Drain Output   [ Time Frame: 24 hours post-operatively ]

8.  Primary:   Number of Autologous Transfusion Units Over the Course of the Hospital Stay   [ Time Frame: perioperatively ]

9.  Primary:   Units of Homologous Transfusion Over the Course of the Hospital Stay   [ Time Frame: three days postoperatively ]

10.  Secondary:   Change in International Normalized Ratio (INR) Level on Day 2 Compared to Preoperatively   [ Time Frame: preoperatively and two days after surgery ]

11.  Secondary:   Range of Motion on Day 3   [ Time Frame: 3 days postoperatively ]

12.  Secondary:   Visual Analog Pain Scale on Day 3   [ Time Frame: 3 days postoperatively ]

13.  Secondary:   Range of Motion at 6 Weeks   [ Time Frame: 6 weeks postoperatively ]

14.  Secondary:   Visual Analog Pain Scale (at Rest) at 6 Weeks   [ Time Frame: 6 weeks postoperatively ]

15.  Secondary:   Visual Analog Pain Scale (During Activity) at 6 Weeks   [ Time Frame: 6 weeks postoperatively ]

16.  Secondary:   Visual Analog Pain Scale (During Therapy) at 6 Weeks   [ Time Frame: 6 weeks postoperatively ]

17.  Secondary:   Visual Analog Pain Scale (At Night) At 6 Weeks   [ Time Frame: 6 weeks postoperatively ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Mark P. Figgie
Organization: Hospital for Special Surgery
phone: 212-606-1932
e-mail: figgiem@hss.edu


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