Clinical trial NCT02616991: Computed Tomography CT Venography During Postpartum Venous Thromboembolism
Official title: Contribution of CT Venography for Diagnosing Venous Thromboembolism During Postpartum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Thromboembolism
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-11-30
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of detected venous thromboembolism (VTE) based on Computed Tomography Angiography (CTA) plus Computed Tomography Venography (CTV)
timeFrame: one day
Secondary outcomes:
measure: Radiation doses due to CT venography
timeFrame: 3 months
measure: kappa coefficients assessing inter-readers agreement for CT venography readings
timeFrame: 3 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Cochin Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Marie-Pierre REVEL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Paris 5 - Rene Descartes
name: Guy MEYER, PhD
role: STUDY_CHAIR
References:
citation: Revel MP, Sanchez O, Dechoux S, Couchon S, Frija G, Cazejust J, Chatellier G, Meyer G. Contribution of indirect computed tomographic venography to the diagnosis of postpartum venous thromboembolism. J Thromb Haemost. 2008 Sep;6(9):1478-81. doi: 10.1111/j.1538-7836.2008.03078.x. Epub 2008 Jul 8.