Postoperative ComplicationsADELCNCT02714673
Management of Patients on Long Term Anticoagulation Therapy Undergoing a Primary Total Hip of Knee Replacement
An observational study of Postoperative Complications, run by Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique at 1 site in France.
Trial summary
It is a multicenter, prospective, observational study of standard care. This study analyses the care of patients on long term effective anticoagulation therapy (ADELC) during a primary hip or knee arthroplasty. The objectives of the study are to: 1. Identify clinical practices set up for patient care 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- anticoagulation
- Type of treatment
- Pill or oral medicine
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2016to 1 Jul 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients on long term effective anticoagulation (ADELC) or not undergoing a primary hip or knee replacement
Who may be able to join
- Adult ≥ 18 years
- Programmed for primary hip or knee arthroplasty.
- Effective dose of anticoagulant drugs intake for more than 1 month with the intention to resume it after the intervention for ADELC cohort; no effective dose of anticoagulant drugs intake for the control cohort.
Who cannot join
- Patient non opposition
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Cochin
Paris, IDF, 75014
David Biau, david.biau@aphp.Fr
About this study
It is a multicenter, prospective, observational study of standard care. This study analyses the care of patients on long term effective anticoagulation therapy (ADELC) during a primary hip or knee arthroplasty.
The objectives of the study are to:
Read more
- Identify clinical practices set up for patient care
- Assess the type and the frequency of perioperative complications
- Look for factors, related to patients or treatments, associated with the occurrence of these complications.
The main objective is to estimate the risks, adjusted and not, of postoperative complications associated to a long term anticoagulation by comparing patients under anticoagulation to a control group of patients having the same interventions but who are not under anticoagulation.
- Conditions
- Postoperative Complications
- Being tested
- anticoagulation
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anticoagulationDrug
anticoagulation refers to any long term effective anticoagulation including antivitamin K, direct oral anticoagulants. Aspirin, clopidogrel are not included
| Study group | Role | What they receive |
|---|---|---|
| ADELC | Cohort of patients on long term anticoagulation and undergoing a primary hip or knee replacement. Receives: Drug: anticoagulation | |
| CONTROL | Cohort of patients not on long term anticoagulation and undergoing a primary hip or knee replacement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
a composite criteria including the occurrence of one or more bleeding complications, major thrombotic events, or reoperation for any reason
Measured: up to 3 months
Secondary outcomes (3)
The length of hospital stay
this is a continuous outcome measured. It measures the number of days from date of entry to the date of hospital discharge
Measured: until end of study, an expected 12 months
The proportion of patients who are transfused during the hospitalization
Measured: up to day 15
The occurrence of a complication of grade 2 or more from Dindo and Clavien classification .
Measured: within 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study start1 Jun 2016
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr David BIAU, Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714673
- Sponsor's protocol ID
- ADECRO
- Acronym
- ADELC
- Status last verified
- Jul 2017
- First submitted
- 7 Mar 2016
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Patients on Long Term Anticoagulation Therapy Undergoing a Primary Total Hip of Knee Replacement
- ClinicalTrials.gov ID
- NCT02714673
- Acronym / sponsor ID
- ADELC / ADECRO
- Conditions
- Postoperative Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et OrthopédiqueUniversity, hospital or other
- Study start
- 1 Jun 2016
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 21 Mar 2016 (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.
It is a multicenter, prospective, observational study of standard care. This study analyses the care of patients on long term effective anticoagulation therapy (ADELC) during a primary hip or knee arthroplasty.
The objectives of the study are to:
- Identify clinical practices set up for patient care
- Assess the type and the frequency of perioperative complications
- Look for factors, related to patients or treatments, associated with the occurrence of these complications.
The main objective is to estimate the risks, adjusted and not, of postoperative complications associated to a long term anticoagulation by comparing patients under anticoagulation to a control group of patients having the same interventions but who are not under anticoagulation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADELC | – | Drug: anticoagulationCohort of patients on long term anticoagulation and undergoing a primary hip or knee replacement. |
| CONTROL | – | –Cohort of patients not on long term anticoagulation and undergoing a primary hip or knee replacement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients on long term effective anticoagulation (ADELC) or not undergoing a primary hip or knee replacement
Key inclusion criteria (3 listed)
- Adult ≥ 18 years
- Programmed for primary hip or knee arthroplasty.
- Effective dose of anticoagulant drugs intake for more than 1 month with the intention to resume it after the intervention for ADELC cohort; no effective dose of anticoagulant drugs intake for the control cohort.
Key exclusion criteria (1 listed)
- Patient non opposition
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 |
|---|---|---|
| anticoagulationanticoagulation refers to any long term effective anticoagulation including antivitamin K, direct oral anticoagulants. Aspirin, clopidogrel are not included | Drug | ADELC |
Primary outcome
a composite criteria including the occurrence of one or more bleeding complications, major thrombotic events, or reoperation for any reason
Time frame: up to 3 months
3 secondary outcomes
The length of hospital stay
Time frame: until end of study, an expected 12 months
The proportion of patients who are transfused during the hospitalization
Time frame: up to day 15
The occurrence of a complication of grade 2 or more from Dindo and Clavien classification .
Time frame: within 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2017.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications, run by Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique at 1 site 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a composite criteria including the occurrence of one or more bleeding complications, major thrombotic events, or reoperation for any reason (time frame: up to 3 months). 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 6 Jul 2017.