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Evicel Study on the Peri-operative Bleeding in Total Knee Prothesis Surgery

NCT00983112 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2012-04-25

No results posted yet for this study

Summary

Knee prothesis surgery is responsible of a risk of thrombosis and hemorrhage. To prevent thrombosis, patients have systematic anticoagulation after surgery which are responsible of hemorrhage. A local glue which improve local coagulation and have no impact of thrombosis can be a solution to limit hemorrhage. The purpose of this trial is to study the impact of a biological glue administration on the bleeding loss at five days after a total knee prosthesis surgery operation.

Conditions

Interventions

DRUG

Human Fibrinogen and human thrombin (Evicel)

Product to be applied intraoperatively. No further administration will take place after this.

DRUG

Sodium Chlorure (Physiological saline)

Sterile concentration, local use.

Sponsors & Collaborators

  • Clinique Mutualiste Chirurgicale de la Loire

    lead OTHER

Principal Investigators

  • Denis BAYLOT, Dr · Clinique Mutualiste Chirurgicale

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-09-30
Completion
2012-12-31

Countries

  • France

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 NCT00983112 on ClinicalTrials.gov