A Phase 4 interventional study of Human Fibrinogen and human thrombin (Evicel) and Sodium Chlorure (Physiological saline) in Thrombosis, sponsored by Clinique Mutualiste Chirurgicale de la Loire. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-04-25.
Sponsored by Clinique Mutualiste Chirurgicale de la Loire · Phase 4, Interventional, and Supportive care
Among 114 studies in Thrombosis with a site in France — 23 open to participants now, 23 under way, 3 of them phase 3. Thrombosis · France.
Among the 114 studies in Thrombosis with a site in France, this one is the 31st largest by planned enrollment of the 55 interventional ones that give a count, is one of 4 that started in 2009, is one of 6 in phase 4, and was the 17th registered.
955 studies on the registry are indexed under Thrombosis; 171 are open to participants now.
Browse Thrombosis studies →23 of the 114 studies in Thrombosis with a site in France are open now. Recruiting first, the newest first:
Fondation Hôpital Saint-Joseph · Sites in France
Assistance Publique - Hôpitaux de Paris · Sites in France
University Hospital, Bordeaux · Sites in France
Centre Hospitalier Universitaire de Saint Etienne · Sites in France
University Hospital, Toulouse · Sites in France
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 126 Thrombosis studies recruiting now, 79 (63%) set no upper age limit and 16 (13%) stop at 75 or younger; 20 take children under 18; 20 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
114 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 8 · Phase 3 21 · Phase 4 6
First in 2004; this study’s year is marked. 4 started in 2009.
This study's planned enrollment of 116 is above the median of 83 across 530 interventional studies indexed under Thrombosis.
Median enrollment 152 across the 55 interventional studies, 200 across the 59 observational. Of the 76 that completed or were terminated, 16 (21%) have results posted.
This tab as a report to print or save as PDF → With an account.
20 of 114 have an industry lead sponsor. The 10 most frequent:
Clinique Mutualiste Chirurgicale de la Loire is the lead sponsor of 3 studies on the registry; none are open to participants now.
Clinique Mutualiste Chirurgicale de la Loire has 1 study filed under Thrombosis — fewer than ten, so there is no comparison to draw.
4 of the studies in Thrombosis with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06749405University Hospital, ToulouseAssessment of a Quantra-guided Transfusion Algorithm in Liver Transplantation | 2027-03 |
| NCT05711173University Hospital, BordeauxClonal Hematopoiesis and NETs Formation in Venous Thrombosis (CLODETTE) | 2027-03 |
| NCT07439939Assistance Publique - Hôpitaux de ParisExploration of Systemic and Portal Hemostasis in Patients Undergoing Transjugular Intrahepatic Portosystemic Shunt Placement | 2027-06-09 |
| NCT06386107Centre Hospitalier Universitaire de Saint EtienneThrombin Generation Parameters and Bleeding in Patients Treated With Anticoagulants for Cancer Associated Thrombosis | 2027-07 |
Among the 114 studies in Thrombosis with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
The orthopaedic surgeon administers a local pulverisation of the biological glue during the surgery.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient affiliated with or a beneficiary of a social security category:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Human Fibrinogen and human thrombin (Evicel)
Drug: Sodium Chlorure (Physiological saline)
Drug pages: Fibrinogen · Thrombin
Product to be applied intraoperatively. No further administration will take place after this.
Also known as: Evicel
Sterile concentration, local use.
Also known as: Physiological saline
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
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
The record gives a start of Sep 2009, a primary completion of Sep 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Fibrinogen · Thrombin
Clinique Mutualiste Chirurgicale de la Loire