A randomised trial comparing four methods of investigating patients with suspected pulmonary thrombo-embolism

ISRCTN	ISRCTN19083957
DOI	https://doi.org/10.1186/ISRCTN19083957
Secondary identifying numbers	HTA 96/07/03

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 24/05/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Alan Moody
Scientific

Department of Medical Imaging
Sunnybrook & Women's Health Sciences Centre, Ontario
2075 Bayview Avenue
Toronto
Ontario
M4N 3M5
Canada

Email	alan.moody@sunnybrook.ca

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title	A randomised trial comparing four methods of investigating patients with suspected pulmonary thrombo-embolism
Study objectives	Diagnosis of pulmonary thrombo-embolus is problematic and there have been recent calls for a change in diagnostic strategy. We intend to investigate the diagnostic effectiveness and cost effectiveness, by studying confidence of diagnosis, and the cost benefit, by studying three month outcome measures (recurrence, complications of treatment, morbidity and mortality), of four imaging protocols in patients suspected of pulmonary thrombo-embolus randomised to these protocols. Results will provide data regarding efficient diagnostic stratagems guiding cost-effective patient management and influencing future capital expenditure.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cardiovascular diseases: Thromboembolic disease
Intervention	A randomised, open clinical trial in a single centre of four investigational protocols: patients are randomised into one of the protocols. 1. V/Q scan +/- lower limb doppler ultrasound +/- clinical assessment of risk 2. V/Q scan +/- lower limb doppler ultrasound +/- conventional pulmonary angiography 3. Contrast enhanced volumetric Computed Tomography (CT) +/- lower limb doppler ultrasound 4. Pulmonary and lower limb Magnetic Resonance Imaging (MRI)
Intervention type	Other
Primary outcome measure	Follow-up will monitor: Days in hospital. Other investigations. Treatment costs. Recurrent thrombo-embolic disease in three months following investigation. Readmission and subsequent costs.
Secondary outcome measures	Not provided at time of registration.
Overall study start date	01/04/1999
Completion date	31/03/2002

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Not provided at time of registration.
Key inclusion criteria	Patients suspected of acute pulmonary embolus normally investigated with ventilation-perfusion (V/Q) radionucleide scanning. 18 years or greater. Giving informed consent.
Key exclusion criteria	Unable to give informed consent. Pregnant. Contraindication to any one of the above protocols.
Date of first enrolment	01/04/1999
Date of final enrolment	31/03/2002

Locations

Countries of recruitment

Canada
United Kingdom

Study participating centre

Department of Medical Imaging

Ontario
M4N 3M5
Canada

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone	+44 (0)1132 545 843
Email	Sheila.Greener@doh.gsi.gov.uk
Website	http://www.dh.gov.uk/en/index.htm
"ROR"	https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

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

Editorial Notes

24/05/2016: No publications found, verifying study status with principal investigator