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

Postoperative Complications Clinical Trial

— ADELC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02714673
• Other study ID #: ADECRO
• Status: Recruiting
• Phase: N/A
• First received: March 7, 2016
• Last updated: July 3, 2017
• Start date: June 1, 2016
• Est. completion date: July 1, 2019

Study information

• Verified date: July 2017
• Source: Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: July 1, 2019
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Cochin	Paris	IDF

Sponsors (1)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The proportion of patients who are transfused during the hospitalization		up to day 15
Secondary	The occurrence of a complication of grade 2 or more from Dindo and Clavien classification .		within 12 months