CompletedPhase 4

Efficacy and Safety of FLOSEAL for Hemostasis in Total Knee Arthroplasty

United States137 participantsStarted 2011-09

Plain-language summary

The purpose of this study is to compare the efficacy and safety of FLOSEAL to standard of care for hemostasis in subjects undergoing total knee arthroplasty.

Who can participate

Age range18 Years – 80 Years

SexALL

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Exclusion criteria

✕. Steroids within the 3 months prior to scheduled surgery,
✕. Synvisc, Hyalin, etc. within the 6 months prior to scheduled surgery

What they're measuring

Change in Hemoglobin (Hgb) Level at Day 2 Post-operatively

Timeframe: Pre-operative and 2 days post-operatively

Proportion of Participants Who Have Adverse Events Related to Investigational Product (IP)

Timeframe: Throughout the study period, 1 year and 4 months

Trial details

NCT IDNCT01410240

SponsorBaxter Healthcare Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-01

Results submitted2014-02-28

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