Use of a Novel Fibrin Sealant in Total Knee Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brett Levine, MD, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01656759
First received: June 14, 2012
Last updated: January 11, 2016
Last verified: January 2016
  Purpose
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.

Condition Intervention Phase
Osteoarthritis
Intraoperative Bleeding
Drug: Evicel Fibrin Spray
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Use of a Novel Fibrin Sealant in Total Knee Arthroplasty: A Prospective Randomized Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Primary--Percent Change of Pre- to Post-Operative Hemoglobin [ Time Frame: Pre-operative to 1 month ] [ Designated as safety issue: No ]
    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.

  • Total Blood Loss [ Time Frame: Collected during surgery and in first 2-3 days after surgery ] [ Designated as safety issue: No ]
    Combination of intraoperative and postoperative blood loss for participants.


Secondary Outcome Measures:
  • Total Transfusions [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    The number of transfusions each patient receives during their postoperative hospitalization.

  • Postoperative Blood Loss [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Measured as drainage output from postoperative drains during hospitalization.


Enrollment: 73
Study Start Date: May 2012
Study Completion Date: August 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Produced by OMRIX Biopharmaceuticals, Ltd.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01656759

Locations
United States, Illinois
Rush Oak Park Hospital
Oak Park, Illinois, United States, 60304
Sponsors and Collaborators
Rush University Medical Center
Investigators
Principal Investigator: Brett R Levine, MD RUMC
  More Information

Publications:
Responsible Party: Brett Levine, MD, Assistant Professor and Associate Residency Director, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01656759     History of Changes
Other Study ID Numbers: 12032202-IRB01 
Study First Received: June 14, 2012
Results First Received: October 27, 2015
Last Updated: January 11, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Rush University Medical Center:
Blood Loss
Hemoglobin
Hematocrit
Blood Transfusions

Additional relevant MeSH terms:
Osteoarthritis
Blood Loss, Surgical
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hemorrhage
Pathologic Processes
Intraoperative Complications
Fibrin Tissue Adhesive
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on July 27, 2016