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Computed Tomography CT Venography During Postpartum Venous Thromboembolism (CTVENPOSTPART)

Primary Purpose

Pulmonary Thromboembolism

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
computed tomography venography
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Thromboembolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cochin Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cohort

Arm Description

computed tomography venography

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Radiation doses due to CT venography
kappa coefficients assessing inter-readers agreement for CT venography readings

Full Information

First Posted
November 25, 2015
Last Updated
April 30, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02616991
Brief Title
Computed Tomography CT Venography During Postpartum Venous Thromboembolism
Acronym
CTVENPOSTPART
Official Title
Contribution of CT Venography for Diagnosing Venous Thromboembolism During Postpartum
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 4, 2016 (Actual)
Primary Completion Date
December 4, 2020 (Actual)
Study Completion Date
April 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Thromboembolism

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort
Arm Type
Experimental
Arm Description
computed tomography venography
Intervention Type
Procedure
Intervention Name(s)
computed tomography venography
Intervention Description
systematically performing computed tomography venography in addition to thoracic computed tomography angiography
Primary Outcome Measure Information:
Title
Number of detected venous thromboembolism (VTE) based on Computed Tomography Angiography (CTA) plus Computed Tomography Venography (CTV)
Description
VTE detection rate for readings based on CTA plus CTV as compared to readings based on CTA alone
Time Frame
one day
Secondary Outcome Measure Information:
Title
Radiation doses due to CT venography
Time Frame
3 months
Title
kappa coefficients assessing inter-readers agreement for CT venography readings
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Pierre REVEL, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guy MEYER, PhD
Organizational Affiliation
University of Paris 5 - Rene Descartes
Official's Role
Study Chair
Facility Information:
Facility Name
Cochin Hospital
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18627442
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.
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Computed Tomography CT Venography During Postpartum Venous Thromboembolism

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