1. To assess four different clinical decision rules (Wells rule, revised Geneva decision rule, simplified Wells rule and simplified revised Geneva decision rule) in the exclusion of pulmonary embolism; 2. To evaluate the safety of withholding…
ID
Bron
Aandoening
Pulmonary embolism
diagnosis
clinical decision rule
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
(Recurrent) pulmonary embolism or deep vein thrombosis.
Achtergrond van het onderzoek
The object of this study is to evaluate four clinical decision rules in the exclusion of pulmonary embolism (Wells rule, revised Geneva score, simplified Wells rule and simplified revised Geneva score). They will be evaluated for safety and clinical utility, both alone and in combination with a D-dimer test. Also, the clinical decision rule according to Wells is evaluated in patients with a suspected recurrent pulmonary embolism: whether it is safe to withhold anticoagulant treatment in patients in whom suspected recurrent pulmonary embolism is excluded based on an unlikely Wells score combined with a normal D-dimer test.
Doel van het onderzoek
1. To assess four different clinical decision rules (Wells rule, revised Geneva decision rule, simplified Wells rule and simplified revised Geneva decision rule) in the exclusion of pulmonary embolism;
2. To evaluate the safety of withholding anticoagulant treatment in patients in whom recurrent PE is excluded on the basis of a pre-specified algorithm (using the Wells rule).
Onderzoeksopzet
Moment of diagnostic workup for PE and 3 month follow up (one telephone call).
Onderzoeksproduct en/of interventie
In case of a first PE, a CT scan is performed in the following combination of tests:
1. Decision rules disagree with each other (one (or more) indicating ‘unlikely’ probability, other(s) indicating a ‘likely’ probability);
2. All four decision rules indicate a ‘likely' probability for PE;
3. All four decision rules indicate an ‘unlikely’ probability for PE but D-dimer is abnormal.
In case of a recurrent pulmonary embolism, the Wells rule will prefer, a CT is performed in case of (figure 1b):
1. A high probability of the Wells score;
2. A combination of a low probability of the Wells score and an abnormal D-dimer.
Publiek
Department of Thrombosis and Haemostasis<br>
Room C4-68<br>
P.O Box 9600
M.V. Huisman
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262085
m.v.huisman@lumc.nl
Wetenschappelijk
Department of Thrombosis and Haemostasis<br>
Room C4-68<br>
P.O Box 9600
M.V. Huisman
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262085
m.v.huisman@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Out- or inpatients with a first episode of clinically suspected pulmonary embolism;
2. Suspected recurrent pulmonary embolism for study question B.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Age < 18 years;
2. Life expectancy < 3 months;
3. Treatment with full-dose therapeutic low molecular weight heparin or unfractionated heparin that was initiated 24 hours or more prior to eligibility assessment;
4. Treatment with vitamin K antagonists (coumarin derivates);
5. Contraindication to helical CT:
A. Allergy to intravenous iodinated contrast;
B. Renal insufficiency (creatinine clearance < 30 ml/min);
C. Pregnancy;
D. Impossibility to return for follow-up.
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 | NL2068 |
NTR-old | NTR2185 |
Ander register | METC LUMC Leiden : P07.266 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |