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

History of Changes

Tracking Information
First Received Date ^ICMJE	October 5, 2009
Last Updated Date	January 11, 2011
Start Date ^ICMJE	October 2007
Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 5, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00990288 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 5, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Use of FLOSEAL to Reduce Bleeding in Total Knee Replacement Surgery
Official Title ^ICMJE	The Role of a Topical Hemostatic Agent in Reducing Blood Loss in Unilateral Total Knee Arthroplasty
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Hemorrhage
Intervention ^ICMJE	Drug: Hemostatic Matrix
Study Arm (s)	Experimental: Hemostatic Matrix 2 vials of Floseal applied once at the end of surgery Intervention: Drug: Hemostatic Matrix No Intervention: No intervention
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	196
Completion Date	Not Provided
Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00990288
Other Study ID Numbers ^ICMJE	26078
Has Data Monitoring Committee	Yes
Responsible Party	Mark Figgie, M.D., Hospital for Special Surgery
Study Sponsor ^ICMJE	Hospital for Special Surgery, New York
Collaborators ^ICMJE	Baxter Healthcare Corporation
Investigators ^ICMJE	Not Provided
Information Provided By	Hospital for Special Surgery, New York
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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