Simple and safe exclusion of pulmonary embolism using quantitative d-dimer and Wells simplified decision rule

ISRCTN	ISRCTN10533382
DOI	https://doi.org/10.1186/ISRCTN10533382
Secondary identifying numbers	NTR757

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr R J Goekoop
Scientific

Leiden University Medical Hospital
C1-45
P.O. Box 9600
Leiden
2300 RC
Netherlands

Study design	Multicentre, randomised, two-armed clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	Excluding pulmonary embolism (PE) by a clinical decision rule (CDR) indicating PE unlikely, assessed by the Wells simplified decision rule, combined with a normal D-dimer is safe and efficient.
Ethics approval(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	Pulmonary embolism, clinically suspected
Intervention	Upon clinical suspicion, Wells clinical decision rule was performed first and if patients had a score of less than 4.0 points, a D-dimer test followed. Patients with a normal D-dimer concentration had no further tests, pulmonary embolism was considered excluded and patients did not receive anticoagulant treatment.
Intervention type	Other
Primary outcome measure	Patients, in whom pulmonary embolism was excluded, were followed up for three months to document the occurrence of venous thromboembolic events or death.
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/03/2002
Completion date	01/06/2004

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	879
Key inclusion criteria	Outpatients with clinically suspected PE
Key exclusion criteria	1. Anticoagulant therapy for more than 24 hours 2. Aged under 18 years 3. Pregnancy 4. Allergy to contrast media 5. Expected survival less than three months 6. Venous thrombo-embolism in the previous six months 7. Refusal or inability to consent
Date of first enrolment	01/03/2002
Date of final enrolment	01/06/2004

Leiden University Medical Hospital

Leiden
2300 RC
Netherlands

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

Department of General Internal Medicine
P.O. Box 9600
Leiden
2300 RC
Netherlands

Website	http://www.lumc.nl/english/start_english.html
"ROR"	https://ror.org/027bh9e22

Hospital/treatment centre

Unrestricted grants from the participating hospitals

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/01/2007		Yes	No