Use of a Novel Fibrin Sealant in Total Knee Arthroplasty

• Sponsor: Rush University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01656759
• Collaborator: (none)
• Enrollment: 73
• Location: 1
• Arms: 2
• Duration (Months): 39
• Patients Per Site Per Month: 1.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis; Intraoperative Bleeding	Drug: Evicel Fibrin Spray	Phase 2/Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 73 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Use of a Novel Fibrin Sealant in Total Knee Arthroplasty: A Prospective Randomized Controlled Clinical Trial
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Primary--Percent Change of Pre- to Post-Operative Hemoglobin [Pre-operative to 1 month]

   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.

2. Total Blood Loss [Collected during surgery and in first 2-3 days after surgery]

   Combination of intraoperative and postoperative blood loss for participants.

Secondary Outcome Measures

1. Total Transfusions [3 days]

   The number of transfusions each patient receives during their postoperative hospitalization.

2. Postoperative Blood Loss [3 days]

   Measured as drainage output from postoperative drains during hospitalization.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Brett Levine, MD, Assistant Professor and Associate Residency Director, Rush University Medical Center
• ClinicalTrials.gov Identifier: NCT01656759
• Other Study ID Numbers: 12032202-IRB01
• First Posted: Aug 3, 2012
• Last Update Posted: Feb 9, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by Brett Levine, MD, Assistant Professor and Associate Residency Director, Rush University Medical Center: Blood Loss; Hemoglobin; Hematocrit; Blood Transfusions
• Additional relevant MeSH terms: Blood Loss, Surgical

Study Results

Participant Flow

Pre-assignment Detail	Prior to randomization, 21 patients were disqualified for protocol violation.

Arm/Group Title	Control Group	Treatment Group--Evicel Fibrin Spray
Arm/Group 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. Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA
Period Title: Overall Study
STARTED	27	25
COMPLETED	25	22
NOT COMPLETED	2	3

Baseline Characteristics

Arm/Group Title	Control Group	Treatment Group--Evicel Fibrin Spray	Total
Arm/Group 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. Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA	Total of all reporting groups
Overall Participants	25	22	47
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	7 28%	12 54.5%	19 40.4%
>=65 years	18 72%	10 45.5%	28 59.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67 (9)	64 (10)	66 (9)
Sex: Female, Male (Count of Participants)
Female	21 84%	17 77.3%	38 80.9%
Male	4 16%	5 22.7%	9 19.1%
Region of Enrollment (participants) [Number]
United States	25 100%	22 100%	47 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Treatment Group--Evicel Fibrin Spray
Arm/Group 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. Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA
Measure Participants	25	22
Mean (Standard Deviation) [Percent Change]	20.1 (7.0)	22.5 (5.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Treatment Group--Evicel Fibrin Spray
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2
	Comments
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Treatment Group--Evicel Fibrin Spray
Arm/Group 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. Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA
Measure Participants	25	22
Mean (Standard Deviation) [mL]	605 (288)	621 (334)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Treatment Group--Evicel Fibrin Spray
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	Total Transfusions
Description	The number of transfusions each patient receives during their postoperative hospitalization.
Time Frame	3 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Treatment Group--Evicel Fibrin Spray
Arm/Group 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. Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA
Measure Participants	25	22
Number [Number of transfusions]	3	3

4. Secondary Outcome

Title	Postoperative Blood Loss
Description	Measured as drainage output from postoperative drains during hospitalization.
Time Frame	3 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Treatment Group--Evicel Fibrin Spray
Arm/Group 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. Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA
Measure Participants	25	22
Mean (Standard Deviation) [mL]	543 (273)	555 (324)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Treatment Group--Evicel Fibrin Spray
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Arm/Group Title	Control Group		Treatment Group--Evicel Fibrin Spray
Arm/Group 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. Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA
All Cause Mortality
	Control Group		Treatment Group--Evicel Fibrin Spray
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control Group		Treatment Group--Evicel Fibrin Spray
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/25 (0%)
Blood and lymphatic system disorders
Deep Vein Thrombosis	0/27 (0%)	0	0/25 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism	0/27 (0%)	0	0/25 (0%)	0
Other (Not Including Serious) Adverse Events
	Control Group		Treatment Group--Evicel Fibrin Spray
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/25 (0%)
Skin and subcutaneous tissue disorders
Superficial Wound Dehiscence	0/27 (0%)	0	0/25 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.