Use of a Novel Fibrin Sealant in Total Knee Arthroplasty

Use of a Novel Fibrin Sealant in Total Knee Arthroplasty: A Prospective Randomized Controlled Clinical Trial

Applying a fibrin spray, after knee device implantation, will help in reducing patient blood loss and decrease the drop in both hemoglobin and hematocrit levels. Also, with decreased blood loss there should be a reduced need for blood transfusions.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Intraoperative Bleeding
• Intervention / Treatment: Drug: Evicel Fibrin Spray

Detailed Description

Study Design

Study design and control methods:

This study is designed as a prospective, randomized, double-blinded controlled clinical trial to compare the effect of a fibrin spray applied to the surgical wound as compared to patients not receiving the fibrin spray.

Treatment group:

The subjects will be randomly assigned to the fibrin treatment group or to the control group at the time of the surgery via the opening of a randomly selected sealed envelope. The patient and the independent reviewer will be blinded as to which treatment group the patient is assigned to. This information will be linked to a confidential database for later review by the principal investigator.

Treatment allocation:

All eligible patients (i.e., meeting inclusion criteria and no exclusion criteria) will be treated and observed per the research protocol. All patients will maintain the right to refuse participation and receive a specific treatment of the study if desired.

Trial Population:

The target sample size is 70 patients for both the treatment and control groups (140 total) with each group split evenly between males and females. There will be one actively enrolling surgeon (Dr. Brett Levine). The goal is to enroll a total of 140 subjects experiencing joint pain that warrants a Total knee arthroplasty (TKA). The specific diagnosis for the joint pain will not direct the subjects' assignment or eligibility at the time of surgery. All 140 patients will be enrolled from the office of the primary investigator (Dr. Brett Levine). All indications for TKA will be included unless one of the exclusion criteria is met.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Oak Park, Illinois, United States, 60304
      • Rush Oak Park Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients must be male or female of any race
• Ages 18-80 years old
• Patients must be undergoing an elective, primary knee arthroplasty performed by the principal investigator

Exclusion Criteria:

• Allergy or intolerance to the study materials
• Surgical intervention during the past month for the treatment of the painful joint or its underlying etiology
• History of previous surgeries on the affected joint including previous arthroscopy (open surgeries)
• Women that are pregnant or may become pregnant
• Patient declines to participate

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Control group. Will not receive the fibrin spray.
Active Comparator: Treatment Group--Evicel Fibrin Spray; Patient will receive the fibrin spray after implantation of device but before the wound is closed. Patients will be randomized to receive spray or not and postop parameters measured.	Drug: Evicel Fibrin Spray; 10cc syringe dose, once at the end of TKA; Other Names: Produced by OMRIX Biopharmaceuticals, Ltd.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary--Percent Change of Pre- to Post-Operative Hemoglobin	Pre-operative hemoglobin values from routine CBC no earlier than 1 month prior to surgery were compared to post-operative hemoglobin values from routine CBC after surgery.	Pre-operative to 1 month
Total Blood Loss	Combination of intraoperative and postoperative blood loss for participants.	Collected during surgery and in first 2-3 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Transfusions	The number of transfusions each patient receives during their postoperative hospitalization.	3 days
Postoperative Blood Loss	Measured as drainage output from postoperative drains during hospitalization.	3 days

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Investigators: Principal Investigator: Brett R Levine, MD, RUMC

Publications and helpful links

General Publications

• Levy O, Martinowitz U, Oran A, Tauber C, Horoszowski H. The use of fibrin tissue adhesive to reduce blood loss and the need for blood transfusion after total knee arthroplasty. A prospective, randomized, multicenter study. J Bone Joint Surg Am. 1999 Nov;81(11):1580-8. doi: 10.2106/00004623-199911000-00010.
• Wang GJ, Hungerford DS, Savory CG, Rosenberg AG, Mont MA, Burks SG, Mayers SL, Spotnitz WD. Use of fibrin sealant to reduce bloody drainage and hemoglobin loss after total knee arthroplasty: a brief note on a randomized prospective trial. J Bone Joint Surg Am. 2001 Oct;83(10):1503-5. doi: 10.2106/00004623-200110000-00007.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: June 14, 2012
• First Submitted That Met QC Criteria: July 31, 2012
• First Posted (Estimate): August 3, 2012

Study Record Updates

• Last Update Posted (Estimate): February 9, 2016
• Last Update Submitted That Met QC Criteria: January 11, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Hemoglobin; Blood Loss; Blood Transfusions; Hematocrit
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Intraoperative Complications; Blood Loss, Surgical
• Other Study ID Numbers: 12032202-IRB01