ThrombosisPhase 4NCT00983112
Evicel Study on the Peri-operative Bleeding in Total Knee Prothesis Surgery
A Phase 4 study testing Human Fibrinogen and human thrombin (Evicel) and Sodium Chlorure (Physiological saline) in people with Thrombosis, run by Clinique Mutualiste Chirurgicale de la Loire at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombosis
- What is being tested?
- Human Fibrinogen and human thrombin (Evicel) and Sodium Chlorure (Physiological saline)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2009to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Saint-Etienne
Saint-Etienne, 42000
MD-PhD
Denis BAYLOT, MD-PhD
About this study
Official title: Impact of a Biological Glue (Evicel®) on the Peri Operative Bleeding in Total Knee Prothesis Surgery
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.
Read the detailed description
The orthopaedic surgeon administers a local pulverisation of the biological glue during the surgery.
- Conditions
- Thrombosis
- Being tested
- Human Fibrinogen and human thrombin (Evicel), Sodium Chlorure (Physiological saline)
- Keywords
- Gonarthrosis, Knee prosthesis insertion, Bleeding, Undergoing a total knee prothesis surgery, knee prothesis surgery, Knee arthrosis, Thrombosis
- Medical subject headings
- Thrombosis, Osteoarthritis, Knee, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Fibrinogen and human thrombin (Evicel)Drug
Also called Evicel
Product to be applied intraoperatively. No further administration will take place after this.
Sodium Chlorure (Physiological saline)Drug
Also called Physiological saline
Sterile concentration, local use.
| Study group | Role | What they receive |
|---|---|---|
| Evicel | Experimental | Not described Receives: Drug: Human Fibrinogen and human thrombin (Evicel) |
| Placebo | Placebo comparator | Not described Receives: Drug: Sodium Chlorure (Physiological saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the impact of a biological glue administration on the bleeding loss at Day 5 after a total knee prosthesis surgery operation
Measured: Day 5
Secondary outcomes (11)
The rate of cell saver transfusion the surgery day
Measured: Day 0
The rate of red blood cell transfusion
Measured: Day 1, Day 3, Day 5 and at the hospitalisation end
The hematoma size
Measured: Day 1, Day 3, Day 5 and at the hospitalisation end
The site incision state
Measured: Day 1, Day 3, Day 5 and at the hospitalisation end
The rest and movement pain
Measured: Day 1, Day 3, Day 5 and at the hospitalisation end
The antalgic consumption
Measured: Day 1, Day 3, Day 5 and at the hospitalisation end
The functional recovering index
Measured: Day 1, Day 3, Day 5, at the hospitalisation end and at 1 month, 3 months and 6 months post-operative
Major rate or clinically significative hemorrhage.
Measured: Between Day 1 and the hospitalisation end
Infectious complications.
Measured: Between Day 1 and the hospitalisation end
The rate of SUSARs.
Measured: Between Day 1 and the end of the study (6 months post-operative)
The rate ot thrombotics events.
Measured: Between Day 1 and the hospitalisation end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Mutualiste Chirurgicale de la Loire
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis BAYLOT, Dr, Principal investigator, Clinique Mutualiste Chirurgicale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00983112
- Sponsor's protocol ID
- 2009-010802-12
- Other IDs
- 2009-003, 2009
- Status last verified
- Apr 2012
- First submitted
- 18 Sep 2009
- Last updated
- 25 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Biological Glue (Evicel®) on the Peri Operative Bleeding in Total Knee Prothesis Surgery
- ClinicalTrials.gov ID
- NCT00983112
- Acronym / sponsor ID
- 2009-010802-12
- Conditions
- Thrombosis
- Keywords
- Gonarthrosis, Knee prosthesis insertion, Bleeding, Undergoing a total knee prothesis surgery, knee prothesis surgery, Knee arthrosis, Thrombosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Clinique Mutualiste Chirurgicale de la LoireUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 23 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The orthopaedic surgeon administers a local pulverisation of the biological glue during the surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evicel | Experimental | Drug: Human Fibrinogen and human thrombin (Evicel) |
| Placebo | Placebo comparator | Drug: Sodium Chlorure (Physiological saline) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient affiliated with or a beneficiary of a social security category:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Fibrinogen and human thrombin (Evicel)Also: EvicelProduct to be applied intraoperatively. No further administration will take place after this. | Drug | Evicel |
| Sodium Chlorure (Physiological saline)Also: Physiological salineSterile concentration, local use. | Drug | Placebo |
Primary outcome
Study the impact of a biological glue administration on the bleeding loss at Day 5 after a total knee prosthesis surgery operation
Time frame: Day 5
11 secondary outcomes
The rate of cell saver transfusion the surgery day
Time frame: Day 0
The rate of red blood cell transfusion
Time frame: Day 1, Day 3, Day 5 and at the hospitalisation end
The hematoma size
Time frame: Day 1, Day 3, Day 5 and at the hospitalisation end
The site incision state
Time frame: Day 1, Day 3, Day 5 and at the hospitalisation end
The rest and movement pain
Time frame: Day 1, Day 3, Day 5 and at the hospitalisation end
The antalgic consumption
Time frame: Day 1, Day 3, Day 5 and at the hospitalisation end
The functional recovering index
Time frame: Day 1, Day 3, Day 5, at the hospitalisation end and at 1 month, 3 months and 6 months post-operative
Major rate or clinically significative hemorrhage.
Time frame: Between Day 1 and the hospitalisation end
Infectious complications.
Time frame: Between Day 1 and the hospitalisation end
The rate of SUSARs.
Time frame: Between Day 1 and the end of the study (6 months post-operative)
The rate ot thrombotics events.
Time frame: Between Day 1 and the hospitalisation end
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis BAYLOT, Dr principal investigator
Clinique Mutualiste Chirurgicale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Human Fibrinogen and human thrombin (Evicel) and Sodium Chlorure (Physiological saline) in people with Thrombosis, run by Clinique Mutualiste Chirurgicale de la Loire at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Denis BAYLOT, MD-PhD (+33(0)477828391, dbaylot@mutualite-loire.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study the impact of a biological glue administration on the bleeding loss at Day 5 after a total knee prosthesis surgery operation (time frame: Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2012.