A randomised trial comparing four methods of investigating patients with suspected pulmonary thrombo-embolism
| ISRCTN | ISRCTN19083957 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19083957 |
| Protocol serial number | HTA 96/07/03 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- 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
Scientific
Department of Medical Imaging
Sunnybrook & Women's Health Sciences Centre, Ontario
2075 Bayview Avenue
Toronto
Ontario
M4N 3M5
Canada
| alan.moody@sunnybrook.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Follow-up will monitor: Days in hospital. Other investigations. Treatment costs. Recurrent thrombo-embolic disease in three months following investigation. Readmission and subsequent costs. |
| Key secondary outcome measure(s) |
Not provided at time of registration. |
| Completion date | 31/03/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| 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
- United Kingdom
- Canada
Study participating centre
Department of Medical Imaging
Ontario
M4N 3M5
Canada
M4N 3M5
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
24/05/2016: No publications found, verifying study status with principal investigator
