The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery - Full Text View

Purpose

Application of "Evicel" hemostatic matrix during operation for unilateral total knee replacement surgery (TKA) will result in decreased bleeding and postoperative drain output, a reduction in transfusion requirements, and less reduction of hemoglobin.

Condition	Intervention	Phase
Patients Age 20-90 Osteoarthritis	Drug: Evicel fibrin sealant	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement Osteoarthritis

U.S. FDA Resources

Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:

Fall in post-operative hemoglobin and hematocrit [ Time Frame: post operative day one and two ] [ Designated as safety issue: No ]
Hemoglobin and hematocrit values will be collected in patients on day one and two post surgery to assess how these values have changed. We hope this product will decrease the drop in these values. We also hope that there will be a decrease in post operative transfusions and that patients will have better clinical outcomes.

Secondary Outcome Measures:

blood loss as measured by constavac drains [ Time Frame: 24 hours post insertion ] [ Designated as safety issue: No ]
Patients will have two constavac drains inserted for 24 hours post surgery. The drain output will be measured at the end of the 24 hours. We hope this product will lead to less bleeding post operatively and therefore better clinical outcomes for patients.
Pain Scores on the Visual Analog Scale [ Time Frame: pre operatively through six week post operatively ] [ Designated as safety issue: No ]
Patients's scale of pain using a visual analogue will be accessed pre operatively, post operatively through day 2 and at six week post operatively. We hypothesize this product will lead to less inflammation, pain and therefore better clinical outcomes.
The change in range of motion pre versus post operatively [ Time Frame: pre operatively through six weeks post operatively ] [ Designated as safety issue: No ]
Patients passive range of motion will be recorded pre operatively, day 2 and at six weeks post operatively. We hope this product will decrease the time it takes for patients knee to return to standard range of motion
Anti-coagulation effects on bleeding [ Time Frame: pre operatively and post operative day 2 ] [ Designated as safety issue: No ]
All patients will take coumadin for deep vein thrombosis prophylaxis as part of the standard of care for the two surgeons involved in this study. Because of this, we will record INR levels pre-operatively and on POD #2. This will act as an important control to ensure minimization of confounding effects of anti-coagulation on bleeding.

Estimated Enrollment:	200
Study Start Date:	September 2010
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Evicel Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.	Drug: Evicel fibrin sealant Used for hemostasis to control bleeding. It has been shown to stop bleeding in 2 minutes or less. It is a combination of a biologic activated component containing human fibrinogen and topical thrombin functioning on wet, actively bleeding tissue.
No Intervention: no evicel Patients will receive standard treatment for bleeding as practiced at HSS.

Arms

Assigned Interventions

Active Comparator: Evicel

Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.

Drug: Evicel fibrin sealant

Used for hemostasis to control bleeding. It has been shown to stop bleeding in 2 minutes or less. It is a combination of a biologic activated component containing human fibrinogen and topical thrombin functioning on wet, actively bleeding tissue.

No Intervention: no evicel

Patients will receive standard treatment for bleeding as practiced at HSS.

Detailed Description:

No additional data desired

Eligibility

Ages Eligible for Study:	20 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of degenerative joint disease of the knee in patients medically suitable to undergo unilateral TKA.
Age range 20-90

Exclusion Criteria:

Known allergies to human blood products.
History of bleeding disorders.
Younger than 20, older than 90
Patients with previous arthrotomy, however, with exception of medial or lateral menisectomy.
Patients taking Lovenox, Plavix, Aggrenox or erythropoetin. (coumadin is acceptable)
Additionally, any patient with an intra-operative complication (i.e bone fracture, vascular injury) or post-operative complication that would affect bleeding tendency will be excluded although data will be recorded for later analysis. Also, any patient who has a complication with the suction drain (eg inadvertently being pulled out, suction failing) will have the remaining data points recorded and drain measurements will be excluded from analysis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01235715

Contacts

Contact: Mark P Figgie, M.D	212-606-1932	figgiem@hss.edu
Contact: Denise M Drinkwater, B.A	646-797-8940	drinkwaterd@hss.edu

Locations

United States, New York
Hospital for Special Surgery	Recruiting
New York, New York, United States, 10021
Contact: Denise Drinkwater 646-797-8940 drinkwaterd@hss.edu
Principal Investigator: Mark Figgie, M.D
Sub-Investigator: Steven Haas, M.D
Sub-Investigator: Han Jo Kim, M.D
Sub-Investigator: Barbara Kahn, R.N.
Sub-Investigator: Denise Drinkwater, B.A.

Sponsors and Collaborators

Hospital for Special Surgery, New York

Ethicon, Inc.

Investigators

Principal Investigator:

Mark P Figgie, M.D

Hospital for Special Surgery, New York

More Information

Additional Information:

Ethicon website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Mark P Figgie, M.D, Hospital for Special Surgery
ClinicalTrials.gov Identifier:	NCT01235715 History of Changes
Other Study ID Numbers:	29054
Study First Received:	October 8, 2010
Last Updated:	June 21, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Hospital for Special Surgery, New York:

osteoarthritis, degenerative joint disease, knee surgery

Additional relevant MeSH terms:

Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Fibrin Tissue Adhesive

Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013