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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
Sponsor:
Information provided by (Responsible Party):
Dr David BIAU, Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique

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:

  1. Identify clinical practices set up for patient care
  2. Assess the type and the frequency of perioperative complications
  3. 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

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort 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.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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

  2. The proportion of patients who are transfused during the hospitalization [ Time Frame: up to day 15 ]
  3. The occurrence of a complication of grade 2 or more from Dindo and Clavien classification . [ Time Frame: within 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients on long term effective anticoagulation (ADELC) or not undergoing a primary hip or knee replacement
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patient non opposition

Information from the National Library of Medicine

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


Locations
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France
Hôpital Cochin Recruiting
Paris, IDF, France, 75014
Contact: David Biau       david.biau@aphp.Fr   
Sponsors and Collaborators
Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique
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Responsible Party: Dr David BIAU, Associate Professor, Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique
ClinicalTrials.gov Identifier: NCT02714673    
Other Study ID Numbers: ADECRO
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes