ThromboembolismPhase 4NCT00362492
Safety Study of Stopping Thromboprophylaxis Based on Ultrasound Results After Total Knee Replacement
A Phase 4 study testing Bilateral ultrasound examination 7+/- 2 after surgery in people with Thromboembolism and Arthroplasty Replacement, Knee, run by University Hospital, Caen at 17 sites in France.
Trial summary
The purpose of this study is to determine whether stopping Low Molecular Weight Heparin (LMWH) thromboprophylaxis is safe after total knee joint replacement. The investigators select patients without proximal thromboembolism assessed by bilateral venous ultrasound examination 7-10 days after surgery. Read more about this study
- Who is it for?
- Ages 46 years and older
- Conditions the study is for
- Thromboembolism, Arthroplasty Replacement, Knee
- What is being tested?
- Bilateral ultrasound examination 7+/- 2 after surgery
- Type of treatment
- Surgery or procedure
- How many people
- 850 participants
- Where
- 17 sitesFrance
- Study dates
- Jun 2004to Jun 2007
- 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 46 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First total knee joint replacement
- Signed informed consent
- Non-inclusion Criteria:
- History of venous thromboembolism/major bleeding/Heparin induced thrombopenia
- Active cancer
- Long-term anticoagulation
Who cannot join
None listed.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
Hospital Alençon
Alençon, 61014
Hospital University Angers
Angers
Clinique du Cèdre
Bois-Guillaume, 76230
Caen University hospital
Caen, 14033
Clinique St Marie
Chalon-sur-Saône, 71100
Hospital Val D'ariège
Foix, 0941
Hospital La Roche sur Yon
La Roche-sur-Yon, 85295
Mignot Hospital
Le Chesnay, 78150
Polyclinique de Riaumont
Liévin, 62800
Hospital University Lille
Lille, 59037
Hospital Nord Mayenne
Mayenne
Montluçon Hospital
Montluçon, 03100
Poitiers University Hospital
Poitiers, 86021
Reims University Hospital
Reims, 51092
Clinique St André
Reims, 51100
Clinique St Jean
Roubaix, 59100
Clinique St Jean Languedoc
Toulouse, 31077
About this study
Official title: 9-10 Days Versus Prolonged Thromboprophylaxis in Patients Without Evidence of Ultrasound Proximal Thromboembolism After Total Knee Joint Replacement: a Randomized Controlled Trial
The purpose of this study is to determine whether stopping Low Molecular Weight Heparin (LMWH) thromboprophylaxis is safe after total knee joint replacement. The investigators select patients without proximal thromboembolism assessed by bilateral venous ultrasound examination 7-10 days after surgery. the investigators hypothesis is that stopping thromboprophylaxis is equally effective than prolonging thromboprophylaxis in order to prevent post-surgery complications in this population.
- Conditions
- Thromboembolism, Arthroplasty Replacement, Knee
- Being tested
- Bilateral ultrasound examination 7+/- 2 after surgery
- Keywords
- TKR, Ultrasonography, asymptomatic deep venous thrombosis, extended duration prophylaxis, short duration prophylaxis
- Medical subject headings
- Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral ultrasound examination 7+/- 2 after surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Thromboembolism occuring between day 7-35 ;
Major bleeding occuring between day 7-35 ;
LMWH induced thrombopenia
All cause mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2006 (estimated)
- Study startJun 2004
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThromboembolismStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Investigators
- Marie-Thérèse Barrellier, MD, Principal investigator, Côte de Nacre University hospitalClaude Vielpeau, MD, Study chair, Côte de Nacre University hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00362492
- Sponsor's protocol ID
- PHRC-Prothege
- Status last verified
- Oct 2010
- First submitted
- 9 Aug 2006
- Last updated
- 28 Oct 2010
- Results posted
- No
Publications
Barrellier MT, Lebel B, Parienti JJ, Mismetti P, Dutheil JJ, Vielpeau C; PROTHEGE study group; GETHCAM study group. Short versus extended thromboprophylaxis after total knee arthroplasty: a randomized comparison. Thromb Res. 2010 Oct;126(4):e298-304. doi: 10.1016/j.thromres.2010.07.018. Epub 2010 Aug 24.
PubMed 20797774
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 9-10 Days Versus Prolonged Thromboprophylaxis in Patients Without Evidence of Ultrasound Proximal Thromboembolism After Total Knee Joint Replacement: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00362492
- Acronym / sponsor ID
- PHRC-Prothege
- Conditions
- Thromboembolism, Arthroplasty Replacement, Knee
- Keywords
- TKR, Ultrasonography, asymptomatic deep venous thrombosis, extended duration prophylaxis, short duration prophylaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Jun 2004
- Study completion
- Jun 2007 (actual)
- First posted
- 10 Aug 2006 (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.
The purpose of this study is to determine whether stopping Low Molecular Weight Heparin (LMWH) thromboprophylaxis is safe after total knee joint replacement. The investigators select patients without proximal thromboembolism assessed by bilateral venous ultrasound examination 7-10 days after surgery. the investigators hypothesis is that stopping thromboprophylaxis is equally effective than prolonging thromboprophylaxis in order to prevent post-surgery complications in this population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 46 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- First total knee joint replacement
- Signed informed consent
- History of venous thromboembolism/major bleeding/Heparin induced thrombopenia
- Active cancer
- Long-term anticoagulation
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Bilateral ultrasound examination 7+/- 2 after surgery | Procedure or surgery | – |
Primary outcome
Thromboembolism occuring between day 7-35 ;
Major bleeding occuring between day 7-35 ;
LMWH induced thrombopenia
All cause mortality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2010.
- Results publication: PubMed 20797774Barrellier MT, Lebel B, Parienti JJ, Mismetti P, Dutheil JJ, Vielpeau C; PROTHEGE study group; GETHCAM study group. Short versus extended thromboprophylaxis after total knee arthroplasty: a randomized comparison. Thromb Res. 2010 Oct;126(4):e298-304. doi: 10.1016/j.thromres.2010.07.018. Epub 2010 Aug 24.
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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.
Marie-Thérèse Barrellier, MD principal investigator
Côte de Nacre University hospital
Claude Vielpeau, MD study chair
Côte de Nacre University hospital
17 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 Bilateral ultrasound examination 7+/- 2 after surgery in people with Thromboembolism and Arthroplasty Replacement, Knee, run by University Hospital, Caen at 17 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 6 inclusion and 0 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 28 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Thromboembolism occuring between day 7-35 ;. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00362492, which also lists 1 linked publication.
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 28 Oct 2010.