Anticoagulation Therapy in the Very Old

Robert Stein132 enrolled

Overview

This study is designed to evaluate the efficacy and safety of warfarin anticoagulation in the very old and attempt to identify risk factors which may impede safe and effective anticoagulation.

This is a prospective registry study with data being collected continuously for 24 months. Patients who have electrocardiographically confirmed atrial fibrillation, are being followed by the Pen Bay Medical Center Anticoagulation Services and are at least 90 years old will be recruited into the study. A matched cohort of patients between the ages of 80 and 89 and another matched cohort of patients between the ages of 70 and 79 will also be recruited into the study for comparison. Data related to adverse events, concomitant medications, living arrangements, mobility and alcohol use will be collected every 6 months. In addition the CHA2DS2-VASc (score for atrial fibrillation stroke risk), HAS - BLED (major bleeding risk score for patients on anticoagulation), frailty and Mini Cog scores will be recalculated at each visit.

Study Type

OBSERVATIONAL

Enrollment

132

Conditions

Atrial Fibrillation

Interventions

WarfarinDRUG

Patients on warfarin for atrial fibrillation

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 70 years of age or older * electrocardiographically confirmed atrial fibrillation * anticipated regular follow up with patient by Penobscot Bay Medical Center (PBMC) Anticoagulation Services * Subject or legally authorized representative must be willing to provide informed consent Exclusion Criteria: \- Patients not being followed by the PBMC Anticoagulation Services

Locations (1)

Penobscot Bay Medical Center

Rockport, Maine, United States

Outcomes

Primary Outcomes

Number of Patients Experiencing Stroke

Every 6 months the medical record was reviewed for evidence of stroke of any cause.

Time frame: 24 months

Number of Patients Experiencing a Major Bleeding Event

defined as one of the following: fatal bleeding, symptomatic bleeding in a critical area or organ or bleeding causing a fall in hemoglobin of 2 g/dl or more or leading to a transfusion of 2 or more units of whole blood or red cells

Time frame: 24 months

Secondary Outcomes

Number of Patients Experiencing a Traumatic Subdural Hemorrhage

Number of subjects who experienced a traumatic subdural hemorrhage in each age group

Time frame: 24 months

Number of Patients Experiencing a Traumatic Intracerebral Hemorrhage

Number of subjects who experienced a traumatic intracerebral hemorrhage in each age group

Time frame: 24 months

Number of Hospitalizations Patients Experienced

Every 6 months the medical record was reviewed for any hospitalizations experienced by the subject within our healthcare system.

Time frame: 24 months

Number of Patients Experiencing Cardiovascular Death

Every 6 months the medical record was reviewed. All deaths were researched for cause and noted if the cause was related to the cardiovascular system.

Time frame: 24 months

Number of Patients Experiencing Death Related to Anticoagulation

All deaths were reviewed in the medical record to determine the cause and if it was related in any way to the use of anticoagulation therapy.

Data from ClinicalTrials.gov

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