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 |
| Protocol serial number | NTR581 |
| Sponsor | Academic Medical Centre (AMC) (The Netherlands) |
| Funders | Amphia Hospital Breda (The Netherlands), Hospital Hilversum (The Netherlands), University Hospital Maastricht (AZM) (The Netherlands), Academic Medical Centre (AMC) (The Netherlands), Erasmus Medical Centre (The Netherlands), University Medical Centre St Radboud (The Netherlands), Meander Medical Centre (The Netherlands), Spaarne Hospital (The Netherlands), Diakonessenhuis Meppel (The Netherlands), Medical Centre Rijnmond, location Zuider Hospital Rijnstate Hospital (The Netherlands) |
- 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
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 |
|---|---|
| m.v.huisman@lumc.nl |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective cohort study |
| Secondary study design | Cohort study |
| 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(s) |
Thromboembolic disease during three months follow-up in all patients. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
2300 RC
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
