The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery

Completed · Phase 4

Conditions studied: Osteoarthritis

In brief

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.

Key facts

Study ID

NCT01235715

Run by

Hospital for Special Surgery, New York

People needed

200

Starts

2010-09-01

Expected to finish

2012-09-01

Last updated by the study team

2013-10-29

Who can join

Age: 20 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of degenerative joint disease of the knee in patients medically suitable to undergo unilateral total knee arthroplasty

You may not qualify if…

• 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.

Where it is running

• Hospital for Special Surgery — New York, New York, United States

Full record on ClinicalTrials.gov

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