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

• Conditions: Postoperative Complications
• Interventions: Drug: anticoagulation

• Registration Number: NCT02714673
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-07
• Study First Submitted QC: 2016-03-16
• Study First Posted: 2016-03-21
• Study Start: 2016-06-01
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-03
• Last Update Posted: 2017-07-06
• Primary Completion: 2018-10-01
• Study Completion: 2019-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The occurrence of a complication of grade 2 or more from Dindo and Clavien classification .	within 12 months
The proportion of patients who are transfused during the hospitalization	up to day 15
The length of hospital stay	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

Trial Locations

Locations (1)

Hôpital Cochin; 🇫🇷 Paris, IDF, France