Condition category
Circulatory System
Date applied
04/04/2006
Date assigned
04/04/2006
Last edited
05/11/2008
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 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 measures

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

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

http://www.amc.uva.nl

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/16403929

Publication citations

  1. 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.

Additional files

Editorial Notes