The Christopher Study: effective management of pulmonary embolism by clinical decision rule (CDR), D-dimer test and helical computed tomography (CT)

ISRCTN	ISRCTN56430379
DOI	https://doi.org/10.1186/ISRCTN56430379
Secondary identifying numbers	NTR581

Submission date: 04/04/2006
Registration date: 04/04/2006
Last edited: 05/11/2008

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 M V Huisman
Scientific

Leiden University Medical Centre (LUMC)
Department of General Internal Medicine, C2-R
P.O. Box 9600
Leiden
2300 RC
Netherlands

Phone	+31 (0)71 625 9111
Email	m.v.huisman@lumc.nl

Study information

Study design	Prospective cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Screening
Scientific title
Study acronym	Christopher Study
Study objectives	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(s)	The institutional review boards of all participating hospitals approved the study protocol.
Health condition(s) or problem(s) studied	Pulmonary embolism (PE)
Intervention	Diagnosis of PE by CDR, D-dimer and helical CT.
Intervention type	Other
Primary outcome measure	Thromboembolic disease during three months follow-up in all patients.
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/11/2002
Completion date	01/12/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	3306
Key inclusion criteria	Adult patients more than 18 years old with clinically suspected pulmonary embolism.
Key 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
Date of first enrolment	01/11/2002
Date of final enrolment	01/12/2004

Locations

Countries of recruitment

Netherlands

Study participating centre

Leiden University Medical Centre (LUMC)

Leiden
2300 RC
Netherlands

Sponsor information

Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Website	http://www.amc.uva.nl
"ROR"	https://ror.org/03t4gr691

Funders

Funder type

Hospital/treatment centre

Amphia Hospital Breda (The Netherlands)

No information available

Hospital Hilversum (The Netherlands)

No information available

University Hospital Maastricht (AZM) (The Netherlands)

No information available

Academic Medical Centre (AMC) (The Netherlands)

No information available

Erasmus Medical Centre (The Netherlands)

No information available

University Medical Centre St Radboud (The Netherlands)

No information available

Meander Medical Centre (The Netherlands)

No information available

Spaarne Hospital (The Netherlands)

No information available

Diakonessenhuis Meppel (The Netherlands)

No information available

Medical Centre Rijnmond, location Zuider Hospital Rijnstate Hospital (The Netherlands)

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	11/01/2006		Yes	No