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 |
- Submission date
- 22/11/2006
- Registration date
- 22/11/2006
- Last edited
- 03/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr R J Goekoop
Scientific
Scientific
Leiden University Medical Hospital
C1-45
P.O. Box 9600
Leiden
2300 RC
Netherlands
Study information
| 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 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Hospital
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Leiden University Medical Centre (LUMC) (The Netherlands)
Hospital/treatment centre
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 |
Funders
Funder type
Hospital/treatment centre
Unrestricted grants from the participating hospitals
No information available
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/01/2007 | Yes | No |
