Major Orthopaedic Surgery and Renal ImpairmentPhase 4PROPICENCT00555438
Prospective, Multicentre, Open-label Study Evaluating 1.5 mg/Day of Fondaparinux.
A Phase 4 study testing fondaparinux 1.5 mg/day in people with Major Orthopaedic Surgery and Renal Impairment, run by Centre Hospitalier Universitaire de Saint Etienne at 29 sites in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Orthopaedic Surgery and Renal Impairment
- What is being tested?
- fondaparinux 1.5 mg/day
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 451 participants
- Where
- 29 sitesFrance
- Study dates
- Jun 2007to Oct 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- • age > 18 years old,
- undergoing a major orthopaedic surgery (THR, TKR, HF) whatever procedure techniques are used, 1st indication or 2nd indication,
- requiring an antithrombotic prophylaxis,
- presenting a renal impairment defined by a creatinin clearance (CrCl) between 20 and 50 ml/min calculated by Cockcroft and Gault's formula,
- having signed the inform consent form.
Who cannot join
- contra-indications to fondaparinux,
- history of heparin inducted thrombopenia (HIT),
- platelets < 100 g/l.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
France29 sites
GARANGER Thierry
Agen, 47000
CHARRET Françoise
Annonay, 07100
BONNEMAISON Julie
Bayonne, 64109
BELLOUCIF Sadek
Bobigny, 93009
SZTARCK François
Bordeaux, 33000
PEGOIX Michel
Caen, 14000
AUSSET Sylvain
Clamart, 92140
SCHOEFFLER Pierre
Clermont-Ferrand, 63000
LETOURNEAU Bernard
Dijon, 21079
TISSIER Dominique
La Roche-sur-Yon, 85016
LEMANISSIER Denis
Le Mans, 72000
CHAMBON Françoise
Lyon, 69006
BEGOU Gérard
Lyon, 69437
CAPDEVILLA Xavier
Montpellier, 34295
PERON Alain
Nantes, 44200
GAERTNER Elisabeth
Nice, 06200
RIPART Jacques
Nîmes, 30029
CHEVALEREAUD Erick
Niort, 79006
LANGERON Olivier
Paris, 75013
RABUEL Christophe
Paris, 75014
MAZUIRE Elisabeth
Paris, 75679
THERY Philippe
Poitiers, 86035
BARRE Jeanne
Reims, 51092
LIGNOT Sophie
Rouen, 76031
MARTIN
Saint-Etienne, 42 055
BAYLOT Denis
Saint-Etienne, 42013
DUVERGER Daniel
Saint-Saulve, 59880
FUZIER Régis
Toulouse, 31059
COUVRET Claude
Tours, 37044
About this study
Official title: Prospective, Multicentre, Open-label Study Evaluating 1.5 mg/Day of Fondaparinux,in Venous Thromboembolic Events Prevention in Patients With Renal Impairment and Undergoing a Major Orthopaedic Surgery. PROPICE Study
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.
Read the detailed description
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
- Being tested
- fondaparinux 1.5 mg/day
- Keywords
- major orthopaedic surgery, venous thromboembolic events prevention, renal impairment, Arixtra, anti-Xa activity
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fondaparinux 1.5 mg/dayDrug
Subcutaneous injection of fondaparinux 1.5 mg/l after major orthopaedic surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery Receives: Drug: fondaparinux 1.5 mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 day
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: at 1 month ± 5
Death at 1 Month ± 5 Days
Evaluate the total number of death at 1 month ± 5 days
Measured: 1 month ± 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2007 (estimated)
- Study startJun 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Major Orthopaedic Surgery and Renal ImpairmentStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- MISMETTI Patrick, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555438
- Sponsor's protocol ID
- 0701017
- Other IDs
- 2007-001048-32
- Acronym
- PROPICE
- Status last verified
- Jul 2011
- First submitted
- 7 Nov 2007
- Last updated
- 17 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentre, Open-label Study Evaluating 1.5 mg/Day of Fondaparinux,in Venous Thromboembolic Events Prevention in Patients With Renal Impairment and Undergoing a Major Orthopaedic Surgery. PROPICE Study
- ClinicalTrials.gov ID
- NCT00555438
- Acronym / sponsor ID
- PROPICE / 0701017
- Keywords
- major orthopaedic surgery, venous thromboembolic events prevention, renal impairment, Arixtra, anti-Xa activity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jun 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 8 Nov 2007 (estimated)
- Results
- Posted 17 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: fondaparinux 1.5 mg/daypatients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • age > 18 years old,
Key exclusion criteria (3 listed)
- contra-indications to fondaparinux,
- history of heparin inducted thrombopenia (HIT),
- platelets < 100 g/l.
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 |
|---|---|---|
| fondaparinux 1.5 mg/daySubcutaneous injection of fondaparinux 1.5 mg/l after major orthopaedic surgery | Drug | 1 |
Primary outcome
Number of Patients With Major Bleedings Between Day 1 and Day 10.
Time frame: 10 day
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.
4 secondary outcomes
Number of Patients With Major Bleedings 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
Time frame: 10 days
Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism at 1 Month ± 5 Days
Time frame: at 1 month ± 5
Death at 1 Month ± 5 Days
Time frame: 1 month ± 5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Major Orthopaedic Surgery and Renal Impairment
Recruiting
Non-invasive Measurement of the Hypotension Prediction Index for the Reduction of Intraoperative Hypotension
Intraoperative Hypotension, Acute Kidney Injury
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.
MISMETTI Patrick, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fondaparinux 1.5 mg/day in people with Major Orthopaedic Surgery and Renal Impairment, run by Centre Hospitalier Universitaire de Saint Etienne at 29 sites 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 17 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites 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. 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?
Yes. Results are posted in the registry (first posted 17 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Major Bleedings Between Day 1 and Day 10. (time frame: 10 day). 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 17 Aug 2011.