ICAD: Clinical validation study of a new algorithm for oral anticoagulant dosing

ISRCTN	ISRCTN27801917
DOI	https://doi.org/10.1186/ISRCTN27801917
Secondary identifying numbers	P02-089; NTR724

Submission date: 26/09/2006
Registration date: 26/09/2006
Last edited: 08/09/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Haematological Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Prof F R Rosendaal
Scientific

Leiden University Medical Center (LUMC)
Department of Clinical Epidemiology
P.O. Box 9600
Leiden
2300 RC
Netherlands

Phone	+31 (0)71 526 4037
Email	f.r.rosendaal@lumc.nl

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Diagnostic
Scientific title
Study acronym	ICAD
Study hypothesis	The equations used by most current algorithms are usually based on a simple pharmacodynamic model, which implies a linear function between the international normalised ratio (INR) and the dosage. Our new algorithm consists of two sub-models in which the first sub-model describes the collective influence of all processes on the effect of the vitamin K antagonist and the second sub-model describes the relationship between the dosage and the corresponding INR. The second sub-model includes a variable parameter to reflect the sensitivity of the patient that may change over time. Because of the inclusion of a parameter that reflects the sensitivity of the patient we think it is better capable of proposing a dosage that leads to an INR within the therapeutic range.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Condition	Anticoagulant treatment
Intervention	Oral anticoagulant dosage supported by the new algorithm (ICAD) and oral anticoagulant dosage supported by the standard algorithm (TRODIS).
Intervention type	Other
Primary outcome measure	1. Percentage of time therapeutic range 2. Proportion of visits in which the algorithm gave a proposal 3. Proportion that was accepted by the physician
Secondary outcome measures	1. Mean time between visits 2. Bleeding events 3. Thrombotic events
Overall study start date	14/08/2003
Overall study end date	01/09/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	712
Participant inclusion criteria	1. Indication for long term anticoagulant therapy 2. Aged between 18 and 80
Participant exclusion criteria	1. Participation in the patient self-management program 2. Staying long periods abroad 3. Terminal stage of disease
Recruitment start date	14/08/2003
Recruitment end date	01/09/2004

Locations

Countries of recruitment

Netherlands

Study participating centre

Leiden University Medical Center (LUMC)

Leiden
2300 RC
Netherlands

Sponsor information

Leiden University Medical Center (LUMC) (The Netherlands)
Hospital/treatment centre

Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands

"ROR"	https://ror.org/05xvt9f17

Funders

Funder type

Industry

Foundation Bazis (now known as iSOFT) (The Netherlands)

No information available

Dutch Thrombosis Foundation (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/05/2005		Yes	No