Pulmonary Thromboembolism
Conditions
Brief summary
The purpose of this study is to determine whether systematically performing computed tomography (CT) venography (i.e a CT acquisition of the pelvis and of the lower limbs, during the venous phase of opacification) in addition to thoracic CT angiography in women with suspected postpartum pulmonary embolism (PE) results in a gain in venous thromboembolism detection rate.
Detailed description
Pulmonary embolism (PE) remains a leading cause of maternal death during postpartum in developed countries; Thoracic computed tomography angiography (CTA) is the first-line diagnostic test for PE suspicion, but has a 20 to 35% rate of inconclusiveness during pregnancy and postpartum, 2 to 3 times higher than that of the general population. CT venography (CTV) consists in a delayed CT acquisition of the abdomen, pelvis and lower limbs, 3 minutes after starting contrast administration. It can be used for detecting deep venous thrombosis (DVT), the source of emboli in most PEs. The investigators hypothesized most postpartum PEs are due to pelvic vein thrombosis and that detecting such pelvic DVT by performing systematic CTV could increase the overall venous thromboembolism (VTE) detection.
Interventions
PROCEDUREcomputed tomography venography
systematically performing computed tomography venography in addition to thoracic computed tomography angiography
Sponsors
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women with clinically suspected pulmonary embolism (PE) during the first 6 weeks postpartum, without any sign of severe PE (shock, hypotension), referred for CT angiography * Absence of contraindication to iodinated contrast medium injection (Previous allergic reaction to iodinated contrast medium, renal insufficiency with creatine clearance less than 30mL/mn, uncontrolled hyperthyroidism) * Age \> 18 years * Health insurance * Possibility to have 3-month follow-up * Obtention of written informed consent (ability to give consent)
Exclusion criteria
* Anticoagulation at therapeutic dosage for another reason than the suspicion of PE for more than 72 hours * New pregnancy (In case of any doubt after medical history review, βHCG blood test must be realized to ensure patient's pregnancy status) * Contrast medium extravasation during injection * CTA or CTV not performed according to the study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of detected venous thromboembolism (VTE) based on Computed Tomography Angiography (CTA) plus Computed Tomography Venography (CTV) | one day | VTE detection rate for readings based on CTA plus CTV as compared to readings based on CTA alone |
Secondary
| Measure | Time frame |
|---|---|
| Radiation doses due to CT venography | 3 months |
| kappa coefficients assessing inter-readers agreement for CT venography readings | 3 months |
Countries
France
Outcome results
None listed