|
ISRCTN
|
ISRCTN56430379
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
The Christopher Study: effective management of pulmonary embolism by clinical decision rule (CDR), D-dimer test and helical computed tomography (CT)
|
|
Scientific title
|
|
|
Acronym
|
Christopher Study
|
|
Serial number at source
|
NTR581
|
|
Study hypothesis
|
It is safe to withhold anticoagulant treatment in patients with clinically suspected pulmonary embolism (PE) who have either a combination of clinical decision rule (CDR) indicating PE unlikely and normal D-dimer test or CDR indicating PE likely or abnormal D-dimer test and normal helical computed tomography (CT).
|
|
Lay summary
|
|
|
Ethics approval
|
The institutional review boards of all participating hospitals approved the study protocol.
|
|
Study design
|
Prospective cohort study
|
|
Countries of recruitment
|
Netherlands
|
|
Disease/condition/study domain
|
Pulmonary embolism (PE)
|
|
Participants - inclusion criteria
|
Adult patients more than 18 years old with clinically suspected pulmonary embolism.
|
|
Participants - exclusion criteria
|
1. Pregnancy
2. Allergy to contrast media
3. No geographic possibility of return for follow-up
4. Treatment with therapeutic heparin for more than 24 hours
5. Indication for thrombolytic therapy
|
|
Anticipated start date
|
01/11/2002
|
|
Anticipated end date
|
01/12/2004
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
3306
|
|
Interventions
|
Diagnosis of PE by CDR, D-dimer and helical CT.
|
|
Primary outcome measure(s)
|
Thromboembolic disease during three months follow-up in all patients.
|
|
Secondary outcome measure(s)
|
No secondary outcome measures
|
|
Sources of funding
|
1. Amphia Hospital Breda (The Netherlands)
2. Hospital Hilversum (The Netherlands)
3. University Hospital Maastricht (AZM) (The Netherlands)
4. Academic Medical Centre (AMC) (The Netherlands)
5. Erasmus Medical Centre (The Netherlands)
6. University Medical Centre St Radboud (The Netherlands)
7. Meander Medical Centre (The Netherlands)
8. Spaarne Hospital (The Netherlands)
9. Diakonessenhuis Meppel (The Netherlands)
10. Medical Centre Rijnmond, location Zuider Hospital Rijnstate Hospital (The Netherlands)
|
|
Trial website
|
|
|
Publications
|
Results in http://www.ncbi.nlm.nih.gov/pubmed/16403929
|
|
Contact name
|
Dr
M V
Huisman
|
|
Address
|
Leiden University Medical Centre (LUMC)
Department of General Internal Medicine, C2-R
P.O. Box 9600
|
|
City/town
|
Leiden
|
|
Zip/Postcode
|
2300 RC
|
|
Country
|
Netherlands
|
|
Tel
|
+31 (0)71 625 9111
|
|
Email
|
m.v.huisman@lumc.nl
|
|
Sponsor
|
Academic Medical Centre (AMC) (The Netherlands)
|
|
Address
|
P.O. Box 22660
|
|
City/town
|
Amsterdam
|
|
Zip/Postcode
|
1100 DD
|
|
Country
|
Netherlands
|
|
Sponsor website:
|
http://www.amc.uva.nl
|
|
Date applied
|
04/04/2006
|
|
Last edited
|
05/11/2008
|
|
Date ISRCTN assigned
|
04/04/2006
|
