Condition category
Circulatory System
Date applied
22/11/2006
Date assigned
22/11/2006
Last edited
03/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr R J Goekoop

ORCID ID

Contact details

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

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

http://www.lumc.nl/english/start_english.html

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

  1. 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.

Additional files

Editorial Notes