Management of Patients on Long Term Anticoagulation Therapy Undergoing a Primary Total Hip of Knee Replacement (ADELC)
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|ClinicalTrials.gov Identifier: NCT02714673|
Recruitment Status : Unknown
Verified July 2017 by Dr David BIAU, Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique.
Recruitment status was: Recruiting
First Posted : March 21, 2016
Last Update Posted : July 6, 2017
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.
|Condition or disease||Intervention/treatment|
|Postoperative Complications||Drug: anticoagulation|
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|Official Title:||Management of Patients on Long Term Anticoagulation Therapy Undergoing a Primary Total Hip of Knee Replacement|
|Study Start Date :||June 1, 2016|
|Estimated Primary Completion Date :||October 1, 2018|
|Estimated Study Completion Date :||July 1, 2019|
Cohort of patients on long term anticoagulation and undergoing a primary hip or knee replacement.
anticoagulation refers to any long term effective anticoagulation including antivitamin K, direct oral anticoagulants. Aspirin, clopidogrel are not included
Cohort of patients not on long term anticoagulation and undergoing a primary hip or knee replacement.
- 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 ]
- The length of hospital stay [ Time Frame: 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 [ 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714673
|Paris, IDF, France, 75014|
|Contact: David Biau david.biau@aphp.Fr|