Canadian Pulmonary Embolism Diagnosis Study (CANPEDS)

Sponsor

Hamilton Health Sciences Corporation (Other)

Overall Status

Terminated

CT.gov ID

NCT00182546

Collaborator

Canadian Institutes of Health Research (CIHR) (Other)

1,126

Enrollment

Locations

Duration (Months)

160.9

Patients Per Site

5.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main objective of the trial is to determine whether D-dimer testing combined with assessment of Pre-Test-Probability (using a standardized clinical model) can be used to markedly simplify the diagnostic process for PE.

It may be safe to omit additional diagnostic testing in selected patients with suspected pulmonary embolism who have a negative D-dimer test

Condition or Disease	Intervention/Treatment	Phase
Suspected Pulmonary Embolism Deep Venous Thrombosis	Procedure: Two diagnostic management strategies	Phase 3

Detailed Description

To assess the value of the D-dimer in the diagnosis of PE, we had two sub-groups of patients with suspected PE, low and high pre-test probability. Patients could be randomized either to further or no further testing.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Canadian Pulmonary Embolism Diagnosis Study

Study Start Date :

Aug 1, 1998

Study Completion Date :

Jan 1, 2001

Outcome Measures

Primary Outcome Measures

DVT or PE during 6 months follow-up []

Secondary Outcome Measures

bleeding []

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with clinically suspected PE

Exclusion Criteria:

Treatment with anticoagulants for greater than 24 hours of performance of D-d
Comorbid condition limiting survival to less than 3 months
Absence of acute symptoms within 7 days prior to presentation
Current pregnancy
Contraindication to contrast (e.g., allergy, renal failure)
Geographic inaccessibility which precludes follow-up
Physician believes patient is inappropriate for study
failure or inability to provide informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queen Elizabeth II Health Sciences Ctr.	Halifax	Nova Scotia	Canada	B3H 1V7
2	Alexander G. Turpie	Hamilton	Ontario	Canada	L8L 2X2
3	McMaster University Medical Centre	Hamilton	Ontario	Canada	L8N 3Z5
4	James Douketis	Hamilton	Ontario	Canada	L8N 4A6
5	HHSC Henderson Campus	Hamilton	Ontario	Canada	L8V 1C3
6	London Health Sciences Centre	London	Ontario	Canada	N6A 4G5
7	Ottawa Civic Hospitals	Ottawa	Ontario	Canada	K1Y 1J8