Completed

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

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What is being tested

Evicel

Drug
Who is being recruted

Arthritis+6

+ Joint Diseases

+ Musculoskeletal Diseases

+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2011
See protocol details

Summary

Principal SponsorUniversity of Milan
Last updated: March 25, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2011

Actual date on which the first participant was enrolled.

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.

Principal SponsorUniversity of Milan
Last updated: March 25, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

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

62 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisJoint DiseasesMusculoskeletal DiseasesOsteoarthritisPathologic ProcessesRheumatic DiseasesPathological Conditions, Signs and SymptomsHemorrhageOsteoarthritis, Knee

Criteria

3 inclusion criteria required to participate
diagnosis of osteoarthritis

patient scheduled for TKR

written informed consent

3 exclusion criteria prevent from participating
Anticoagulation therapy or any anti-aggregate treatment not suspended at least 4 days before surgery

Hb pre-operative level lower than 12g/dl for man and 11g/dl for woman

previous intervention on the same Knee (except for meniscectomy)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

No Intervention

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Unità Operativa Ortopedia e Traumatologia II Policlinico San Donato

San Donato Milanese, ItalyOpen Unità Operativa Ortopedia e Traumatologia II Policlinico San Donato in Google Maps
CompletedOne Study Center