Pulmonary embolism diagnosis study

ISRCTN	ISRCTN65486961
DOI	https://doi.org/10.1186/ISRCTN65486961
Secondary identifying numbers	MCT-44150

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr David Robert Anderson
Scientific

Queen Elizabeth II Health Science Centre
VGH Site, Room 430
Bethune Building
1278 Tower Road
Halifax
B3H 2Y9
Canada

Phone	+1 902 473 8562
Email	david.anderson@dal.ca

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	We hypothesise that relying on the use of spiral Computed Tomography (CT) as opposed to V/Q scanning as the initial pulmonary imaging procedure to exclude the diagnosis of PE will result in similar rates of subsequent venous thromboembolic events and will be cost-effective.
Ethics approval(s)	Ethics approval received from the Queen Elizabeth II Health Sciences Centre Research Ethics Committee on the 8th March 2001.
Health condition(s) or problem(s) studied	Pulmonary embolism (PE)
Intervention	Clinical model to identify PE likely or unlikely, Ddimer blood test, randomised to receive either V/Q or CT for diagnosis of possible PE, in majority of cases would have ultrasound to rule out deep vein thrombosis. Trial details received: 12 September 2005
Intervention type	Other
Primary outcome measure	Symptomatic venous thromboembolism.
Secondary outcome measures	1. Asymptomatic venous thromboembolism 2. Death 3. Bleed (major and minor)
Overall study start date	01/11/2005
Completion date	31/07/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	1530
Key inclusion criteria	Consecutive adult patients (18 years and older) of either sex, presenting with symptoms or signs suspected by a physician of being caused by acute pulmonary embolism (acute onset of new or worsening shortness of breath, chest pain, hemoptysis, presyncope or syncope) will be potentially eligible for this study.
Key exclusion criteria	1. Deep vein thrombosis or pulmonary embolism within the previous 3 months 2. No worsening of the severity of pulmonary symptoms within the previous 2 weeks 3. Use of therapeutic doses of parenteral anticoagulants for greater than 48 hours 4. Co-morbid condition making life expectancy less than 3 months 5. Contradiction to contrast media 6. A need for long-term use of anticoagulants 7. Pregnancy 8. Age less than 18 years 9. Refusal to give informed consent 10. Geographic inaccessibility to follow-up
Date of first enrolment	01/11/2005
Date of final enrolment	31/07/2006

Queen Elizabeth II Health Science Centre

Halifax
B3H 2Y9
Canada

Queen Elizabeth II Health Science Centre (Nova Scotia) (Canada)
Hospital/treatment centre

1278 Tower Road
Halifax
B3H 2Y9
Canada

Email	Susan.Pleasance@cdha.nshealth.ca
"ROR"	https://ror.org/025qrzc85

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-44150)

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	19/12/2007		Yes	No