The Use of FLOSEAL to Reduce Bleeding in Total Knee Replacement Surgery

This study has been completed.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by:
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT00990288
First received: October 5, 2009
Last updated: January 11, 2011
Last verified: October 2009

October 5, 2009
January 11, 2011
October 2007
August 2010   (final data collection date for primary outcome measure)
  • Fall in post-operative hemoglobin and hematocrit. Data will be collected from laboratory tests [ Time Frame: before surgery and the first and second days after surgery ] [ Designated as safety issue: No ]
  • Drain output in milliliters at 24 hours. This will be recorded from the time the drain was inserted. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Transfusion requirements - The total number of units, along with the individual number of autologous and homologous units required for each patient will be recorded. [ Time Frame: The three days following surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00990288 on ClinicalTrials.gov Archive Site
  • Range of Motion [ Time Frame: 3 days after surgery, 6 weeks after surgery ] [ Designated as safety issue: No ]
  • Pain scores [ Time Frame: 3 days after surgery, 6 weeks after surgery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Use of FLOSEAL to Reduce Bleeding in Total Knee Replacement Surgery
The Role of a Topical Hemostatic Agent in Reducing Blood Loss in Unilateral Total Knee Arthroplasty

The purpose of this study is to determine if the agent, Floseal, can decrease the amount of blood patients lose after total knee replacement (TKR) surgery. If this product can be found to have an effect on bleeding, it may potentially reduce the problems associated with bleeding after knee replacement surgery such as pain, stiffness, and the need to have a blood transfusion. The subject's overall participation will be over a period of 6 weeks.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Hemorrhage
Drug: Hemostatic Matrix
  • Experimental: Hemostatic Matrix
    2 vials of Floseal applied once at the end of surgery
    Intervention: Drug: Hemostatic Matrix
  • No Intervention: No intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
196
Not Provided
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Single Knee replacement for arthritis of the knee

Exclusion Criteria:

  • No inflammatory arthritis (ie. Rheumatoid arthritis)
  • No allergies to cow meat (bovine allergies
  • No history of bleeding disorders
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00990288
26078
Yes
Mark Figgie, M.D., Hospital for Special Surgery
Hospital for Special Surgery, New York
Baxter Healthcare Corporation
Not Provided
Hospital for Special Surgery, New York
October 2009

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