Use of a Novel Fibrin Sealant in Total Knee Arthroplasty
Primary Purpose
Osteoarthritis, Intraoperative Bleeding
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Evicel Fibrin Spray
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Blood Loss, Hemoglobin, Hematocrit, Blood Transfusions
Eligibility 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
Sites / Locations
- Rush Oak Park Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control Group
Treatment Group--Evicel Fibrin Spray
Arm Description
Control group. Will not receive the 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.
Outcomes
Primary Outcome Measures
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.
Total Blood Loss
Combination of intraoperative and postoperative blood loss for participants.
Secondary Outcome Measures
Total Transfusions
The number of transfusions each patient receives during their postoperative hospitalization.
Postoperative Blood Loss
Measured as drainage output from postoperative drains during hospitalization.
Full Information
NCT ID
NCT01656759
First Posted
June 14, 2012
Last Updated
January 11, 2016
Sponsor
Rush University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01656759
Brief Title
Use of a Novel Fibrin Sealant in Total Knee Arthroplasty
Official Title
Use of a Novel Fibrin Sealant in Total Knee Arthroplasty: A Prospective Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Intraoperative Bleeding
Keywords
Blood Loss, Hemoglobin, Hematocrit, Blood Transfusions
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control group. Will not receive the fibrin spray.
Arm Title
Treatment Group--Evicel Fibrin Spray
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Evicel Fibrin Spray
Other Intervention Name(s)
Produced by OMRIX Biopharmaceuticals, Ltd.
Intervention Description
10cc syringe dose, once at the end of TKA
Primary Outcome Measure Information:
Title
Primary--Percent Change of Pre- to Post-Operative Hemoglobin
Description
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.
Time Frame
Pre-operative to 1 month
Title
Total Blood Loss
Description
Combination of intraoperative and postoperative blood loss for participants.
Time Frame
Collected during surgery and in first 2-3 days after surgery
Secondary Outcome Measure Information:
Title
Total Transfusions
Description
The number of transfusions each patient receives during their postoperative hospitalization.
Time Frame
3 days
Title
Postoperative Blood Loss
Description
Measured as drainage output from postoperative drains during hospitalization.
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brett R Levine, MD
Organizational Affiliation
RUMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush Oak Park Hospital
City
Oak Park
State/Province
Illinois
ZIP/Postal Code
60304
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
10565650
Citation
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.
Results Reference
result
PubMed Identifier
11679600
Citation
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.
Results Reference
result
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Use of a Novel Fibrin Sealant in Total Knee Arthroplasty
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