Management of Patients on Long Term Anticoagulation Therapy Undergoing a Primary Total Hip of Knee Replacement

NCT ID: NCT02714673

Last Updated: 2017-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-01

Study Completion Date

2019-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ADELC

Cohort of patients on long term anticoagulation and undergoing a primary hip or knee replacement.

anticoagulation

Intervention Type DRUG

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.

No interventions assigned to this group

Interventions

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anticoagulation

anticoagulation refers to any long term effective anticoagulation including antivitamin K, direct oral anticoagulants. Aspirin, clopidogrel are not included

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique

OTHER

Sponsor Role lead

Responsible Party

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Dr David BIAU

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hôpital Cochin

Paris, IDF, France

Site Status RECRUITING

Countries

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France

Facility Contacts

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David Biau

Role: primary

Other Identifiers

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ADECRO

Identifier Type: -

Identifier Source: org_study_id

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