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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-001048-32 | EudraCT Number |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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Fondaparinux is an antithrombotic agent having already received a regulatory approval by the European Authorities in venous thromboembolic event prevention after major orthopaedic surgery, as total hip replacement (THR), total knee replacement (TKR), hip fracture (HF). The bleeding risk associated with this prescription is highly related to renal function evaluated by creatinin clearance (CrCl). In order to reduce the bleeding risk, it has been proposed to prescribe fondaparinux 1.5 mg/day in patients with a CrCl between 20 and 50ml/mn instead of 2.5mg/day (European MMA). In the meantime, this approval is essentially based on simulated pharmakinetic data without any support of clinical data.
prospective, multicentre, open-label study evaluating the safety profile of fondaparinux 1.5 mg/day, subcutaneously administered, in patients with a renal impairment defined by a CrCl between 20 and 30 ml/min and undergoing a major orthopaedic surgery.
Fondaparinux 1.5mg/day subcutaneously administered during post-surgery 1 to 10 days with the 1st treatment administration performed 6 to 8 hours after the end of surgery.
Screening visit : > 7 days before inclusion visit if THR and TKR Inclusion visit : day of surgery Visits with blood drawing: 3 visits scheduled during 1 to 10 days of treatment period Study end of treatment visit: D1 to D10 Study end visit: 1 month ± 15 days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fondaparinux 1.5 mg/day | Drug | Subcutaneous injection of fondaparinux 1.5 mg/l after major orthopaedic surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Major Bleedings Between Day 1 and Day 10. | evaluate between Day 1 and Day 10, the number of patients under study treatment who has affected by major bleedings defined as fatal, involved a critical organ, treatment cessation, occurred at the surgical site and necessitated any medical intervention, or if it was overt and necessitated transfusion of >2 units of packed red blood cells or was associated with a fall in hemoglobin >20 g/L. | 10 day |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Major Bleedings at 1 Month ± 5 Days. | evaluate the number of patients affected by major bleedings defined as fatal, involved a critical organ, treatment cessation, occurred at the surgical site and necessitated any medical intervention, or if it was overt and necessitated transfusion of >2 units of packed red blood cells or was associated with a fall in hemoglobin >20 g/L at 1 month ± 5 days. |
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Inclusion Criteria:
• age > 18 years old,
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MISMETTI Patrick, MD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GARANGER Thierry | Agen | 47000 | France | |||
| CHARRET Françoise |
Nine patients received no study drug due to immediate postoperative death (n=1), consent withdrawal (n=2), use of another thromboprophylactic agent (n=2), surgery change or cancellation (n=2), and CrCl >50 mL/min just before surgery (n=2)
patients have been included between june 2007 and june 2008 in public and private French hospitals
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| ID | Title | Description |
|---|---|---|
| FG000 | Fondaparinux 1.5 mg/l | patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 10 Days Post-operative |
|
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| 45 day |
| Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism Between Day 1 and Day 10 | Evaluate the number of patients affected by symptomatic Deep Vein Thrombosis (any symptomatic distal and/or proximal deep-vein thrombosis) and Pumonary Embolism (symptomatic pulmonary embolism confirmed by objective tests) between Day 1 and Day 10. | 10 days |
| Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism at 1 Month ± 5 Days | Evaluate the number of patients affected by symptomatic Deep Vein Thrombosis (any symptomatic distal and/or proximal deep-vein thrombosis) and Pumonary Embolism (symptomatic pulmonary embolism confirmed by objective tests) at 1 month ± 5 days. | at 1 month ± 5 |
| Death at 1 Month ± 5 Days | Evaluate the total number of death at 1 month ± 5 days | 1 month ± 5 days |
| Annonay |
| 07100 |
| France |
| BONNEMAISON Julie | Bayonne | 64109 | France |
| BELLOUCIF Sadek | Bobigny | 93009 | France |
| SZTARCK François | Bordeaux | 33000 | France |
| PEGOIX Michel | Caen | 14000 | France |
| AUSSET Sylvain | Clamart | 92140 | France |
| SCHOEFFLER Pierre | Clermont-Ferrand | 63000 | France |
| LETOURNEAU Bernard | Dijon | 21079 | France |
| TISSIER Dominique | La Roche-sur-Yon | 85016 | France |
| LEMANISSIER Denis | Le Mans | 72000 | France |
| CHAMBON Françoise | Lyon | 69006 | France |
| BEGOU Gérard | Lyon | 69437 | France |
| CAPDEVILLA Xavier | Montpellier | 34295 | France |
| PERON Alain | Nantes | 44200 | France |
| GAERTNER Elisabeth | Nice | 06200 | France |
| CHEVALEREAUD Erick | Niort | 79006 | France |
| RIPART Jacques | Nîmes | 30029 | France |
| LANGERON Olivier | Paris | 75013 | France |
| RABUEL Christophe | Paris | 75014 | France |
| MAZUIRE Elisabeth | Paris | 75679 | France |
| THERY Philippe | Poitiers | 86035 | France |
| BARRE Jeanne | Reims | 51092 | France |
| LIGNOT Sophie | Rouen | 76031 | France |
| MARTIN | Saint-Etienne | 42 055 | France |
| BAYLOT Denis | Saint-Etienne | 42013 | France |
| DUVERGER Daniel | Saint-Saulve | 59880 | France |
| FUZIER Régis | Toulouse | 31059 | France |
| COUVRET Claude | Tours | 37044 | France |
| COMPLETED |
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| NOT COMPLETED |
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| Between 10 Days and 30 Days Postoperativ |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fondaparinux 1.5 mg/l | patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Major Bleedings Between Day 1 and Day 10. | evaluate between Day 1 and Day 10, the number of patients under study treatment who has affected by major bleedings defined as fatal, involved a critical organ, treatment cessation, occurred at the surgical site and necessitated any medical intervention, or if it was overt and necessitated transfusion of >2 units of packed red blood cells or was associated with a fall in hemoglobin >20 g/L. | Posted | Number | participants | 10 day |
|
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| |||||||||||||||||||||||||||
| Secondary | Number of Patients With Major Bleedings at 1 Month ± 5 Days. | evaluate the number of patients affected by major bleedings defined as fatal, involved a critical organ, treatment cessation, occurred at the surgical site and necessitated any medical intervention, or if it was overt and necessitated transfusion of >2 units of packed red blood cells or was associated with a fall in hemoglobin >20 g/L at 1 month ± 5 days. | Posted | Number | participants | 45 day |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism Between Day 1 and Day 10 | Evaluate the number of patients affected by symptomatic Deep Vein Thrombosis (any symptomatic distal and/or proximal deep-vein thrombosis) and Pumonary Embolism (symptomatic pulmonary embolism confirmed by objective tests) between Day 1 and Day 10. | Posted | Number | participants | 10 days |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism at 1 Month ± 5 Days | Evaluate the number of patients affected by symptomatic Deep Vein Thrombosis (any symptomatic distal and/or proximal deep-vein thrombosis) and Pumonary Embolism (symptomatic pulmonary embolism confirmed by objective tests) at 1 month ± 5 days. | Posted | Number | participants | at 1 month ± 5 |
|
| ||||||||||||||||||||||||||||
| Secondary | Death at 1 Month ± 5 Days | Evaluate the total number of death at 1 month ± 5 days | Posted | Number | participants | 1 month ± 5 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fondaparinux 1.5 mg/l | patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery | 32 | 442 | 0 | 442 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hiatus hernia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Infarction mesenteric | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| gastrointestinal disorder NOS | Gastrointestinal disorders | Systematic Assessment |
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| Gastroduodenal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| distal intestinal obstruction syndrome | Gastrointestinal disorders | Systematic Assessment |
| ||
| proctorrhagia | Gastrointestinal disorders | Systematic Assessment |
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| Small intestine obstruction | Gastrointestinal disorders | Systematic Assessment |
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| Gastrointestinal obstruction NOS | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhea, Clostridium difficile | Infections and infestations | Systematic Assessment |
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| septic shock | Infections and infestations | Systematic Assessment |
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| Bronchopulmonary infection | Infections and infestations | Systematic Assessment |
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| incision site infection | Infections and infestations | Systematic Assessment |
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| prosthesis fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| incision site hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
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| anemia postoperative | Injury, poisoning and procedural complications | Systematic Assessment |
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| incision site inflammation | Injury, poisoning and procedural complications | Systematic Assessment |
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| femoral greater trochanter fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Fracture of neck of femur | Injury, poisoning and procedural complications | Systematic Assessment |
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| deep vein thrombosis postoperative | Injury, poisoning and procedural complications | Systematic Assessment |
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| acute coronary syndrome | Cardiac disorders | Systematic Assessment |
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| acute myocardial infarction | Cardiac disorders | Systematic Assessment |
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| Atrial fibrillation paroxysmal | Cardiac disorders | Systematic Assessment |
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| cardio-respiratory failure | Cardiac disorders | Systematic Assessment |
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| transient cerebral ischemia | Nervous system disorders | Systematic Assessment |
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| ischemic strocke | Nervous system disorders | Systematic Assessment |
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| acute pulmonary edaema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumothorax NOS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Respiratort insufficiency | Reproductive system and breast disorders | Systematic Assessment |
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| mesenteric ischemia | Vascular disorders | Systematic Assessment |
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| malaise | General disorders | Systematic Assessment |
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| general physical health deterioration | General disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr patrick MISMETTI | CHU SAINT-ETIENNE | 33(1)477127788 | patrick.mismetti@chu-st-etienne.fr |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077425 | Fondaparinux |
| ID | Term |
|---|---|
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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