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

March 22, 2013 updated by: Pietro Randelli, MD, University of Milan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milano
      • San Donato Milanese, Milano, Italy
        • Unità Operativa Ortopedia e Traumatologia II Policlinico San Donato

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Evicel
Drug: Evicel
Evicel (5ml) is sprayed over the soft tissue after the implant of prosthetic components and before wounding closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fall in post-operative hemoglobin level after total knee replacement
Time Frame: First 7 days after surgery
Hemoglobin values are collected in patients in first week post surgery to assess how these values have changed.
First 7 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total blood loss
Time Frame: until 7 day after surgery

Calculation of perioperative blood loss is based on changes in hemoglobin (Hb) level. Assuming that the blood volume V0 on the seventh day after surgery is the same as that before surgery the loss of Hb is estimated according to the following formula:

Hb-loss (g) =V0 (l)×(Hbpre-op (g/l)-Hb7day post-op(g/l))+Hb-transfused (g) where:

  • Hb-loss (g) is the amount of hemoglobin lost
  • Hbpre-op (g/l) is the hemoglobin level before surgery
  • Hb7day post-op (g/l) is the hemoglobin level in postoperative day 7
  • Hb-transfused (g) is the total amount of allogeneic hemoglobin transfused; a unit of banked blood is considered to contain 52 g of hemoglobin.
  • V0 (l) is the total blood volume of patient and it is calculated using the formula of Nadler:

V0male(l)=0.3669×height(m)3+0.03219×weight(Kg)+0.6041 V0female(l)=0.3561×height(m)3+0.0338×weight(Kg)+0.1833

The total blood loss is calculated as follows:

Blood loss(l)=Hb-loss(g)/Hbpre-op(g/l)
until 7 day after surgery
Blood Transfusion rate
Time Frame: until 1 week after Surgery
Number of patients requiring 1 or more unit of allogenic banked blood
until 1 week after Surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

March 15, 2013

First Submitted That Met QC Criteria

March 19, 2013

First Posted (Estimate)

March 22, 2013

Study Record Updates

Last Update Posted (Estimate)

March 25, 2013

Last Update Submitted That Met QC Criteria

March 22, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bleeding Control

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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