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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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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

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Total Knee Replacement Primary Knee Arthroplasty Osteoarthritis of the Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Evicel

Group Type EXPERIMENTAL

Evicel

Intervention Type DRUG

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

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Evicel

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patient scheduled for TKR
* written informed consent
* diagnosis of osteoarthritis

Exclusion Criteria

* previous intervention on the same Knee (except for meniscectomy)
* Hb pre-operative level lower than 12g/dl for man and 11g/dl for woman
* Anticoagulation therapy or any anti-aggregate treatment not suspended at least 4 days before surgery

Eligible Sex

ALL

Accepts Healthy Volunteers

No