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

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: Postoperative Complications
• Intervention / Treatment: Drug: anticoagulation

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

Study Locations

• France
  • IDF
    • Paris, IDF, France, 75014
      • Recruiting
      • Hopital Cochin
      • Contact: David Biau; Email: david.biau@aphp.Fr

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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	up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The length of hospital stay	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		up to day 15
The occurrence of a complication of grade 2 or more from Dindo and Clavien classification .		within 12 months

Collaborators and Investigators

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

Study record dates

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: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: ADECRO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED