Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR757
Study information
Scientific title
Acronym
Study hypothesis
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
Received from the local medical ethics committee
Study design
Multicentre, randomised, two-armed clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/03/2002
Overall trial end date
01/06/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Outpatients with clinically suspected PE
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
879
Participant 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
Recruitment start date
01/03/2002
Recruitment end date
01/06/2004
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Hospital
Leiden
2300 RC
Netherlands
Sponsor information
Organisation
Leiden University Medical Centre (LUMC) (The Netherlands)
Sponsor details
Department of General Internal Medicine
P.O. Box 9600
Leiden
2300 RC
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Unrestricted grants from the participating hospitals
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/pubmed/17200782
Publication citations
-
Results
Goekoop RJ, Steeghs N, Niessen RW, Jonkers GJ, Dik H, Castel A, Werker-van Gelder L, Vlasveld LT, van Klink RC, Planken EV, Huisman MV, Simple and safe exclusion of pulmonary embolism in outpatients using quantitative D-dimer and Wells' simplified decision rule., Thromb. Haemost., 2007, 97, 1, 146-150.