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

July 3, 2017 updated by: Dr David BIAU, Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients on long term effective anticoagulation (ADELC) or not undergoing a primary hip or knee replacement

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
until end of study, an expected 12 months
The proportion of patients who are transfused during the hospitalization
Time Frame: up to day 15
up to day 15
The occurrence of a complication of grade 2 or more from Dindo and Clavien classification .
Time Frame: within 12 months
within 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (ANTICIPATED)

October 1, 2018

Study Completion (ANTICIPATED)

July 1, 2019

Study Registration Dates

First Submitted

March 7, 2016

First Submitted That Met QC Criteria

March 16, 2016

First Posted (ESTIMATE)

March 21, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 6, 2017

Last Update Submitted That Met QC Criteria

July 3, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADECRO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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