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

Hospital for Special Surgery (HSS)

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis

Treatments: Drug: Evicel fibrin sealant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01235715

29054

Details and patient eligibility

About

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.

Full description

No additional data desired

Enrollment: 200 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Evicel

Active Comparator group

Description:

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.

Treatment:

Drug: Evicel fibrin sealant

no evicel

No Intervention group

Description:

Patients will receive standard treatment for bleeding as practiced at the Hospital for Special Surgery.