CTVENPOSTPART: Computed Tomography CT Venography During Postpartum Venous Thromboembolism

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Completed
• CT.gov ID: NCT02616991
• Collaborator: (none)
• Enrollment: 125
• Location: 1
• Arm: 1
• Actual Duration (Months): 57.9
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Thromboembolism	Procedure: computed tomography venography	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 125 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Contribution of CT Venography for Diagnosing Venous Thromboembolism During Postpartum
• Actual Study Start Date: Jun 4, 2016
• Actual Primary Completion Date: Dec 4, 2020
• Actual Study Completion Date: Apr 2, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort computed tomography venography	Procedure: computed tomography venography; systematically performing computed tomography venography in addition to thoracic computed tomography angiography

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Radiation doses due to CT venography [3 months]

2. kappa coefficients assessing inter-readers agreement for CT venography readings [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cochin Hospital	Paris		France	75014

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: Marie-Pierre REVEL, MD, PhD, Assistance Publique - Hôpitaux de Paris
• Study Chair: Guy MEYER, PhD, University of Paris 5 - Rene Descartes

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT02616991
• Other Study ID Numbers: 2015-002741-64; 2015-A01262-47
• First Posted: Nov 30, 2015
• Last Update Posted: May 4, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Pulmonary Embolism; Thromboembolism; Venous Thromboembolism

Study Results

No Results Posted as of May 4, 2021