ICAD: Clinical validation study of a new algorithm for oral anticoagulant dosing
| ISRCTN | ISRCTN27801917 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27801917 |
| Protocol serial number | P02-089; NTR724 |
| Sponsor | Leiden University Medical Center (LUMC) (The Netherlands) |
| Funders | Foundation Bazis (now known as iSOFT) (The Netherlands), Dutch Thrombosis Foundation (The Netherlands) |
- 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 of protocol
Not provided at time of registration
Contact information
Prof F R Rosendaal
Scientific
Scientific
Leiden University Medical Center (LUMC)
Department of Clinical Epidemiology
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 526 4037 |
|---|---|
| f.r.rosendaal@lumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | ICAD |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) | 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 |
| Key secondary outcome measure(s) | 1. Mean time between visits 2. Bleeding events 3. Thrombotic events |
| Completion date | 01/09/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 712 |
| Key inclusion criteria | 1. Indication for long term anticoagulant therapy 2. Aged between 18 and 80 |
| Key exclusion criteria | 1. Participation in the patient self-management program 2. Staying long periods abroad 3. Terminal stage of disease |
| Date of first enrolment | 14/08/2003 |
| Date of final enrolment | 01/09/2004 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Center (LUMC)
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
