NCT01816282

The Use of Fibrin Sealant to Reduce Bleeding After Total Knee Replacement

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: University of Milan · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

A randomized controlled study is performed to address the question of whether the topical application of a novel fibrin sealant, Evicel (Johnson \& Johnson Wound Management, Ethicon, Somerville, NJ) in patient undergoing total knee replacement (TKR) reduce the perioperative blood loss and the need for allogenic blood transfusion compared to a control group. We hypothesize that fibrin sealant decrease the drop in post-operative hemoglobin level after total knee replacement.

Detailed description

Total knee replacement is an invasive surgical procedure that can expose patients to massive perioperative bleeding. This hematic loss results in a high rate of blood transfusion after total knee replacement (TKR) with an incidence from 10% to 58%.Methods to prevent the need for allogenic blood transfusion after TKR include hemodilution, perioperative blood salvage and reinfusion, hypotensive anesthesia, preoperative autologous blood donation and intravenous administration of tranexamic acid. In the last decade, the topical use of fibrin sealant has become a logical surgical stratagem for reducing blood loss in total knee arthroplasty.Fibrin sealants mimic the final step of the coagulation cascade reducing blood loss and transfusion requirements. A novel hemostatic agent derived from banked allogenic human plasma (EVICEL, Johnson \& Johnson Wound Management, Ethicon, Somerville, NJ) is recently available on the market for a variety of surgical specialty. A randomized controlled study is conducted to test if the post-operative reduction in hemoglobin level would be lower in the fibrin sealant group compared to a control group.

Conditions

• Total Knee Replacement
• Primary Knee Arthroplasty
• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	Evicel	Evicel (5ml) is sprayed over the soft tissue after the implant of prosthetic components and before wounding closure

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-04-01
• Completion: 2012-06-01
• First posted: 2013-03-22
• Last updated: 2013-03-25

Locations

1 site across 1 country: Italy