NCT00983112

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
116

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 23, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 25, 2012

Status Verified

April 1, 2012

Enrollment Period

3 years

First QC Date

September 18, 2009

Last Update Submit

April 24, 2012

Conditions

Thrombosis

Keywords

GonarthrosisKnee prosthesis insertionBleedingUndergoing a total knee prothesis surgeryknee prothesis surgeryKnee arthrosisThrombosis

Outcome Measures

Primary Outcomes (1)

  • Study the impact of a biological glue administration on the bleeding loss at Day 5 after a total knee prosthesis surgery operation

    Day 5

Secondary Outcomes (11)

  • The rate of cell saver transfusion the surgery day

    Day 0

  • The rate of red blood cell transfusion

    Day 1, Day 3, Day 5 and at the hospitalisation end

  • The hematoma size

    Day 1, Day 3, Day 5 and at the hospitalisation end

  • The site incision state

    Day 1, Day 3, Day 5 and at the hospitalisation end

  • The rest and movement pain

    Day 1, Day 3, Day 5 and at the hospitalisation end

  • +6 more secondary outcomes

Study Arms (2)

Evicel

EXPERIMENTAL
Drug: Human Fibrinogen and human thrombin (Evicel)

Placebo

PLACEBO COMPARATOR
Drug: Sodium Chlorure (Physiological saline)

Interventions

Human Fibrinogen and human thrombin (Evicel)DRUG

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

Also known as: Evicel
Evicel
Sodium Chlorure (Physiological saline)DRUG

Sterile concentration, local use.

Also known as: Physiological saline
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient affiliated with or a beneficiary of a social security category:
  • having more than 18 years old
  • having signed the informed consent form
  • having undergone a total knee prosthesis surgery operation

You may not qualify if:

  • incapacity to understand the protocol
  • patient having taken anti-coagulants or clopidogrel 10 days before excepted aspirin to a dose equal or less than 160 mg/day
  • women having period so generally women having less than 50 years old
  • PT less than 60% and ACT taller than 10 sec
  • contra-indications to the drug
  • Erytropoietine treatment required before surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, 42000, France

RECRUITING

MeSH Terms

Conditions

ThrombosisOsteoarthritis, KneeHemorrhage

Interventions

FibrinogenThrombin

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesOsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acute-Phase ProteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBlood Coagulation FactorsProtein PrecursorsBiological FactorsSerine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine Proteases

Study Officials

  • Denis BAYLOT, Dr

    Clinique Mutualiste Chirurgicale

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Denis BAYLOT, MD-PhD

CONTACT

+33(0)477828391dbaylot@mutualite-loire.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2009

First Posted

September 23, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2012

Study Completion

December 1, 2012

Last Updated

April 25, 2012

Record last verified: 2012-04

Locations

FR(1)