A Phase 4 interventional study of fondaparinux 1.5 mg/day in Major Orthopaedic Surgery and Renal Impairment, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 29 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-08-17.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Phase 4, Interventional, and Prevention
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
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 451 is above the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.
Counted across the registry records on this site, refreshed daily.
age > 18 years old,
Exclusion Criteria:
patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
Drug: fondaparinux 1.5 mg/day
Subcutaneous injection of fondaparinux 1.5 mg/l after major orthopaedic surgery
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.
Time frame: 10 day
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.
Time frame: 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.
Time frame: 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.
Time frame: at 1 month ± 5
Death at 1 Month ± 5 Days
Evaluate the total number of death at 1 month ± 5 days
Time frame: 1 month ± 5 days
patients have been included between june 2007 and june 2008 in public and private French hospitals
| Milestone | Fondaparinux 1.5 mg/l |
|---|---|
| Started | 442 |
| Completed | 438 |
| Not completed | 4 |
| Withdrew: Death | 4 |
| Milestone | Fondaparinux 1.5 mg/l |
|---|---|
| Started | 438 |
| Completed | 433 |
| Not completed | 5 |
| Withdrew: Death | 5 |
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.
| participants | Fondaparinux 1.5 mg/l |
|---|---|
| Number of Patients With Major Bleedings Between Day 1 and Day 10. | 20 |
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.
| participants | Fondaparinux 1.5 mg/l |
|---|---|
| Number of Patients With Major Bleedings at 1 Month ± 5 Days. | 23 |
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.
| participants | Fondaparinux 1.5 mg/l |
|---|---|
| Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism Between Day 1 and Day 10 | 2 |
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.
| participants | Fondaparinux 1.5 mg/l |
|---|---|
| Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism at 1 Month ± 5 Days | 3 |
Evaluate the total number of death at 1 month ± 5 days
| participants | Fondaparinux 1.5 mg/l |
|---|---|
| Death at 1 Month ± 5 Days | 10 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fondaparinux 1.5 mg/l | — | 32/442 (7.2%) | 0/442 (0%) |
| Event | Fondaparinux 1.5 mg/l |
|---|---|
| incision site infectionInfections and infestations | 3/442 |
| incision site hematomaInjury, poisoning and procedural complications | 3/442 |
| septic shockInfections and infestations | 2/442 |
| acute coronary syndromeCardiac disorders | 2/442 |
| acute pulmonary edaemaRespiratory, thoracic and mediastinal disorders | 2/442 |
| general physical health deteriorationGeneral disorders | 2/442 |
| Hiatus herniaGastrointestinal disorders | 1/442 |
| Infarction mesentericGastrointestinal disorders | 1/442 |
| VomitingGastrointestinal disorders | 1/442 |
| gastrointestinal disorder NOSGastrointestinal disorders | 1/442 |
| Age, Categorical(Participants) | Fondaparinux 1.5 mg/l |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 5 |
| >=65 years | 437 |
| Age Continuous(years) | Fondaparinux 1.5 mg/l |
|---|---|
| Mean | 81.4 ± 6.64 |
| Sex: Female, Male(Participants) | Fondaparinux 1.5 mg/l |
|---|---|
| Female | 353 |
| Male | 89 |
| Region of Enrollment(participants) | Fondaparinux 1.5 mg/l |
|---|---|
| France | 442 |
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Centre Hospitalier Universitaire de Saint Etienne