NCT02616991

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 30, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

June 4, 2016

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2021

Completed
Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

4.5 years

First QC Date

November 25, 2015

Last Update Submit

September 1, 2025

Conditions

Pulmonary Thromboembolism

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Radiation doses due to CT venography

    3 months

  • kappa coefficients assessing inter-readers agreement for CT venography readings

    3 months

Study Arms (1)

Cohort

EXPERIMENTAL

computed tomography venography

Procedure: computed tomography venography

Interventions

computed tomography venographyPROCEDURE

systematically performing computed tomography venography in addition to thoracic computed tomography angiography

Cohort

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cochin Hospital

Paris, Paris, 75014, France

Location

Related Publications (2)

  • Revel MP, Chassagnon G, Sanchez O, Ferretti G, Millet I, Rocher L, Maitre S, Lederlin M, Ducou-le-Pointe H, Rousset P, Bennani S, Zins M, Bruneau B, Tissot V, Alison M, Canniff E, Siauve N, Vandeventer S, Le Blanche AF, Planquette B, Tsatsaris V, Coste J. CT venography for the diagnosis of postpartum venous thromboembolism: a prospective multi-center cohort study. Eur Radiol. 2024 Nov;34(11):7419-7428. doi: 10.1007/s00330-024-10791-8. Epub 2024 May 23.

    PMID: 38782788BACKGROUND

  • 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.

    PMID: 18627442BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Marie-Pierre REVEL, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

  • Guy MEYER, PhD

    University of Paris 5 - Rene Descartes

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2015

First Posted

November 30, 2015

Study Start

June 4, 2016

Primary Completion

December 4, 2020

Study Completion

April 2, 2021

Last Updated

September 8, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)