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

NCT02714673 | Unknown

• 1 other identifier: ADECRO
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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. 1.Identify clinical practices set up for patient care
2. 2.Assess the type and the frequency of perioperative complications
3. 3.Look for factors, related to patients or treatments, associated with the occurrence of these complications.

Conditions

Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The length of hospital stay

  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

Study Arms (2)

ADELC

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

Drug: anticoagulation

CONTROL

Cohort of patients not on long term anticoagulation and undergoing a primary hip or knee replacement.

Interventions

anticoagulation DRUG

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

ADELC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Patient non opposition

Sponsors & Collaborators

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

Study Sites (1)

Hôpital Cochin

Paris, IDF, 75014, France

RECRUITING

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: March 21, 2016
• Study Start: June 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: July 1, 2019
• Last Updated: July 6, 2017

Record last verified: 2017-07

Locations

FR (1)