Contact information
Type
Scientific
Primary contact
Dr M V Huisman
ORCID ID
Contact details
Leiden University Medical Centre (LUMC)
Department of General Internal Medicine
C2-R
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 625 9111
m.v.huisman@lumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR581
Study information
Scientific title
Acronym
Christopher Study
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).
Ethics approval
The institutional review boards of all participating hospitals approved the study protocol.
Study design
Prospective cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Condition
Pulmonary embolism (PE)
Intervention
Diagnosis of PE by CDR, D-dimer and helical CT.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Thromboembolic disease during three months follow-up in all patients.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/11/2002
Overall trial end date
01/12/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Adult patients more than 18 years old with clinically suspected pulmonary embolism.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
3306
Participant 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
Recruitment start date
01/11/2002
Recruitment end date
01/12/2004
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Centre (LUMC)
Leiden
2300 RC
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (The Netherlands)
Sponsor details
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Amphia Hospital Breda (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Hospital Hilversum (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University Hospital Maastricht (AZM) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Academic Medical Centre (AMC) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Erasmus Medical Centre (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University Medical Centre St Radboud (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Meander Medical Centre (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Spaarne Hospital (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Diakonessenhuis Meppel (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Medical Centre Rijnmond, location Zuider Hospital Rijnstate Hospital (The Netherlands)
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
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/16403929
Publication citations
-
Results
van Belle A, Büller HR, Huisman MV, Huisman PM, Kaasjager K, Kamphuisen PW, Kramer MH, Kruip MJ, Kwakkel-van Erp JM, Leebeek FW, Nijkeuter M, Prins MH, Sohne M, Tick LW, , Effectiveness of managing suspected pulmonary embolism using an algorithm combining clinical probability, D-dimer testing, and computed tomography., JAMA, 2006, 295, 2, 172-179, doi: 10.1001/jama.295.2.172.