By developing a model which predicts the risk of bleeding with coumarin use, patients can be treated more effectively, potentially avoiding the need for specific antidotes. Besides decreasing the risk of bleeding (potentially resulting in less…
ID
Bron
Aandoening
Eng: bleeding complications while using coumarins (vitamin K antagonist)
keywords: bleeding - coumarin - vitamin K antagonist - prediction model - risk factor
Dutch: Bloedingscomplicaites bij gebruik van coumarines (vitamine K antagonisten)
bloeding - coumarine - vitamine K antagonist - voorspelmodel - risico factor
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
INR > 4.5.
Achtergrond van het onderzoek
Reduction of (avoidable) errors is one of the key goals of the patient safety program within Dutch healthcare in general and within the Erasmus MC in specific. This pilot project for identifying patients with a high risk of bleeding complications while using coumarins fits this goal.
Using electronic patient data, risk factors for a high risk of bleeding complications will be identified and a clinical prediction model for potential bleeding complications will be developed. This prediction model can be used on hospitalized patients using coumarins. A high INR (international normalized ratio), and/or use of the coumarin antidotes vitamin K and prothrombin complex concentrate (PCC), use of tranexamic acid, blood transfusions and death serve as indicators to identify these patients.
The objective is the identification of electronically available risk factors and the development of a clinical prediction model to identify patients at risk for a bleeding complication while using coumarins.
It is a (nested) case control study in hospitalized patients with one or more prescriptions of coumarins, in the four year period 2006-2009. This study will be carried out using (historically) documented electronic patient data. All patient data are coded using non-traceable codes.
Patients with an INR > 4.5 are generally regarded as being at high risk for a bleeding complication. Regression analysis will be used for data-analysis, using 'backward selection' to select the strongest predictors for having a high INR in a multivariate regression model.
Doel van het onderzoek
By developing a model which predicts the risk of bleeding with coumarin use, patients can be treated more effectively, potentially avoiding the need for specific antidotes. Besides decreasing the risk of bleeding (potentially resulting in less morbidity and mortality), such a prediction model may also lead to a reduction in healthcare costs.
Onderzoeksopzet
Adult patients admitted in 2006-2009 will be included in this study.
Onderzoeksproduct en/of interventie
It is a nested case control study. Identification of risk factors for bleeding complications in patients using coumarins. With these risk factors a clinical prediction model for high risk of bleeding in patients using coumarins will be developed.
Publiek
A.D. Lindemans
Rotterdam 3015 CE
The Netherlands
+31 (0)10 7033202
A.Lindemans@erasmusmc.nl
Wetenschappelijk
A.D. Lindemans
Rotterdam 3015 CE
The Netherlands
+31 (0)10 7033202
A.Lindemans@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Hospitalized patients => 18 yr with an prescription for a coumarin within the 4-year period 2006-2009.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
N/A
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL2551 |
NTR-old | NTR2669 |
Ander register | METC Erasmus MC, Rotterdam the Netherlands : 2010-287 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |