ADELC: Management of Patients on Long Term Anticoagulation Therapy Undergoing a Primary Total Hip of Knee Replacement
Study Details
Study Description
Brief 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:
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Identify clinical practices set up for patient care
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Assess the type and the frequency of perioperative complications
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| ADELC Cohort of patients on long term anticoagulation and undergoing a primary hip or knee replacement. |
Drug: anticoagulation
anticoagulation refers to any long term effective anticoagulation including antivitamin K, direct oral anticoagulants. Aspirin, clopidogrel are not included
|
| CONTROL Cohort of patients not on long term anticoagulation and undergoing a primary hip or knee replacement. |
Outcome Measures
Primary Outcome Measures
- a composite criteria including the occurrence of one or more bleeding complications, major thrombotic events, or reoperation for any reason [up to 3 months]
Secondary Outcome Measures
- The length of hospital stay [until end of study, an expected 12 months]
this is a continuous outcome measured. It measures the number of days from date of entry to the date of hospital discharge
- The proportion of patients who are transfused during the hospitalization [up to day 15]
- The occurrence of a complication of grade 2 or more from Dindo and Clavien classification . [within 12 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult ≥ 18 years
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Programmed for primary hip or knee arthroplasty.
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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.
Exclusion Criteria:
- Patient non opposition
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital Cochin | Paris | IDF | France | 75014 |
Sponsors and Collaborators
- Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ADECRO