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The Christopher Study.


- candidate number1955
- NTR NumberNTR581
- ISRCTNISRCTN56430379
- Date ISRCTN created4-apr-2006
- date ISRCTN requested24-mrt-2006
- Date Registered NTR30-jan-2006
- Secondary IDsN/A 
- Public TitleThe Christopher Study.
- Scientific TitleEffective management of pulmonary embolism by clinical decision rule (CDR), D-dimer test and helical CT.
- ACRONYMChristopher Study
- hypothesisIt is safe to withhold anticoagulant treatment in patients with clinically suspected PE who have either a combination of CDR indicating PE unlikely and normal D-dimer test or CDR indicating PE likely or abnormal D-dimer test and normal helical CT.
- Healt Condition(s) or Problem(s) studiedPulmonary embolism
- Inclusion criteriaAdult patients more than 18 years old with clinically suspected pulmonary embolism.
- Exclusion criteria1. Pregnancy;
2. Allergy to contrast media;
3. No geographic possibility to return for follow-up;
4. Treatment with therapeutic heparin for more than 24 hours;
5. Indication for thrombolytic therapy.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 1-nov-2002
- planned closingdate1-dec-2004
- Target number of participants3306
- InterventionsDiagnosis of PE by CDR, D-dimer and helical CT.
- Primary outcomeThromboembolic disease during three months follow-up in all patients.
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD. PhD. M.V. Huisman
- CONTACT for SCIENTIFIC QUERIESMD. PhD. M.V. Huisman
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam, Academic Hospital Maastricht (AZM), University Medical Center St. Radboud, Erasmus Medical Center, Meander Medical Center Amersfoort, Hospital Hilversum, Diakonessenhuis Meppel, Spaarne Hospital, Medical Center. Rijnmond, location Zuiderhospital Rijnstate Hospital, Amphia Hospital Breda
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), University Medical Center St. Radboud, Erasmus Medical Center, University Hospital Maastricht (AZM), Meander Medical Center Amersfoort, Hospital Hilversum , Diakonessenhuis Meppel, Spaarne Hospital, Medical Center Rijnmond, location Zuider Hospital Rijnstate Hospital, Amphia Hospital Breda
- Publications1. JAMA 2006; 295: 172-179;


2. Thromb Haemost. 2007 Jun;97(6):944-8.
- Brief summary3503 eligible patients of whom 197 excluded (5%);


VTE complications during follow-up in patients with initial normal tests:
1. in patients with CDR indicating PE unlikely and normal D-dimer 0.5 %;
2. in patients with normal helical CT: 1.3 %.
- Main changes (audit trail)
- RECORD30-jan-2006 - 23-jun-2008


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