MedTrace Logo

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

NCT01235715 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2013-10-29

Study results available
· View outcomes & findings →

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

Interventions

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.

Sponsors & Collaborators

  • Ethicon, Inc.

    collaborator INDUSTRY

  • Hospital for Special Surgery, New York

    lead OTHER

Principal Investigators

  • Mark P Figgie, M.D · Hospital for Special Surgery, New York

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-03-31
Completion
2012-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01235715 on ClinicalTrials.gov