Dabigatran trough levels in elderly patients: are these increased, and to what extent? A pilot study.

Dabigatran trough levels in elderly patients: are these increased, and to what extent? A pilot study. - Dabigatran trough levels in elderly.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50084

Enrollment

Registered

2017-05-29

Start date

2017-08-17

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bleeding risk prolonged clotting time

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Outpatients from cardiology or geriatric clinic. Dabigatran use since at least 1 week. Dabigatran dose 2 times daily, 110 or 150 mg. Indication for dabigatran: atrial fibrillation.

Exclusion criteria

Exclusion criteria: Use of trombocyte aggregation inhibitors. Use of PgP inhibitors. Limitation in renal function, clearance (CKD-epi)

Design outcomes

Primary

Measure	Time frame
Primary parameter is the dabigatran trough level, which will be analyzed by multivariate linear regression, with age and renal function as covariates. Besides this, also median values per age category ( 85 years) will be shown and compared. Because of correction for dose, all concentrations will be shown als ng/ml/mg.	—

Secondary

Measure	Time frame
Secondary outcomes are: 1) the percentage of each age group having dabigatran trough levels higher than 150 ng/ ml; 2.) the amount and percentage of glucuronidated dabigatran, and relation to the age of the patient; 3.) the clotting time as diluted thrombin time and it's relation to dabigatran level and to the amount of glucuronidated dabigatran.	—

Countries

Netherlands

Outcome results