The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery

NCT01235715 | Completed Phase 4 Results

• 1 other identifier: 29054
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis

Keywords

osteoarthritis; total knee replacement

Outcome Measures

Primary Outcomes (9)

• Change in Hemoglobin on Day 0 Compared to Preoperatively

  preoperatively and on the day of surgery

• Change in Hematocrit on Day 0 Compared to Preoperatively

  preoperatively and day of surgery

• Change in Hemoglobin On Day 1 Compared to Preoperatively

  preoperatively and one day after surgery

• Change in Hematocrit on Day 1 Compared to Preoperatively

  preoperatively and one day after surgery

• Change in Hemoglobin on Day 2 Compared to Preoperatively

  preoperatively and two days after surgery

• Change in Hematocrit on Day 2 Compared to Preoperatively

  preoperatively and two days after surgery

• Drain Output

  A measurement of the amount of blood drained from the knee.

  24 hours post-operatively

• Number of Autologous Transfusion Units Over the Course of the Hospital Stay

  Units of autologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.

  perioperatively

• Units of Homologous Transfusion Over the Course of the Hospital Stay

  Units of homologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.

  three days postoperatively

Secondary Outcomes (8)

• Change in International Normalized Ratio (INR) Level on Day 2 Compared to Preoperatively

  preoperatively and two days after surgery

• Range of Motion on Day 3

  3 days postoperatively

• Visual Analog Pain Scale on Day 3

  3 days postoperatively

• Range of Motion at 6 Weeks

  6 weeks postoperatively

• Visual Analog Pain Scale (at Rest) at 6 Weeks

  6 weeks postoperatively

Study Arms (2)

Evicel

ACTIVE COMPARATOR

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

no evicel

NO INTERVENTION

Patients will receive standard treatment for bleeding as practiced at the Hospital for Special Surgery.

Interventions

Evicel fibrin sealant DRUG

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.

Evicel

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Diagnosis of degenerative joint disease of the knee in patients medically suitable to undergo unilateral total knee arthroplasty

You may not qualify if:

• Known allergies to human blood products.
• History of bleeding disorders.
• 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.

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead
• Ethicon, Inc.: collaborator

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Links

• Ethicon website

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Dr. Mark P. Figgie
• Organization: Hospital for Special Surgery

figgiem@hss.edu

212-606-1932

Study Officials

• Mark P Figgie, M.D

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2010
• First Posted: November 5, 2010
• Study Start: September 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 29, 2013
• Results First Posted: October 29, 2013

Record last verified: 2013-08

Locations

US (1)