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Individual versus general information about certain risks of medication in patients with a high risk for adverse drug reaction

Individual versus general information about certain risks of medication in patients with a high risk for adverse drug reaction - IDrug

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00006256
Enrollment
960
Registered
2015-01-09
Start date
2014-09-29
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

coagulation problems, Bleeding events, thromboembolic events D68.30 D68.31 D68.32 D68.38 D68.4 D68.8 I26.0 I26.9 I74.0 I74.1 I74.2 I74.3 I74.4 I74.5 I74.8 I74.9

Interventions

Group 1: The following parameters will be included in the individualized pharmacotherapeutical risk information: - genetical analysis (CYP2C9, CYP2C19, VCORC1) - drug- drug interaction test - liver v

Sponsors

Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: multimorbidity, therapy with oral anticoagulation, minimum of one additional medication over a longer period of time, can give written consent to take part in the study

Exclusion criteria

Exclusion criteria: is not able to give consent ot take part in that study, is not able to understand and/or fill in the questionaire SF-36 and other forms

Design outcomes

Primary

MeasureTime frame
Bleeding occurence or occurence of a thromboembolic event during the observation period of 9 month

Secondary

MeasureTime frame
morbidity: serious adverse drug reaction during the observation period of 9 month. Number of hospitailzation due to serious adverse drug reaction. Number of specialist's referral due do problems with the medication. Number of change in medication during the observation period of 9 month. mortality: number of death during the observation period of 9 month. Effectiveness: qualtiy of life (SF-36; 3,6, and 9 month after start of the study). Cost of medication and of potantil additional doctor’s visit. cost-benefit analysis (that takes mobidity and mortality into account)

Countries

Germany

Contacts

Public ContactKathrin Kastenmüller

Universitätsklinikum Bonn, Institut für Hausarztmedizin

kkastenm@uni-bonn.de0228 287 13739

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 13, 2026