Computed Tomography CT Venography During Postpartum Venous Thromboembolism

Pulmonary Thromboembolism Clinical Trial

— CTVENPOSTPART  

Official title:

Contribution of CT Venography for Diagnosing Venous Thromboembolism During Postpartum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02616991
• Other study ID #: 2015-002741-64
• Secondary ID: 2015-A01262-47
• Status: Completed
• Phase: N/A
• Start date: June 4, 2016
• Est. completion date: April 2, 2021

Study information

• Verified date: April 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: April 2, 2021
• Est. primary completion date: December 4, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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, ßHCG 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

Related Conditions & MeSH terms

• Pulmonary Embolism
• Pulmonary Thromboembolism
• Thromboembolism
• Venous Thromboembolism

Intervention

Procedure:
• computed tomography venography
systematically performing computed tomography venography in addition to thoracic computed tomography angiography

Locations

Country	Name	City	State
France	Cochin Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of detected venous thromboembolism (VTE) based on Computed Tomography Angiography (CTA) plus Computed Tomography Venography (CTV)	VTE detection rate for readings based on CTA plus CTV as compared to readings based on CTA alone	one day
Secondary	Radiation doses due to CT venography		3 months
Secondary	kappa coefficients assessing inter-readers agreement for CT venography readings		3 months