NCT01457963

Brief Summary

The primary objective of this study was to estimate the prevalence of PE among consecutive ICU patients receiving MV who required thoracic computed tomography (CT) with contrast agent injection, regardless of whether PE was suspected clinically. The secondary objectives were to assess the association between PE and DVT, to identify risk factors for VTE, and to determine the outcome of VTE.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
176

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2009

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

Study Start

First participant enrolled

December 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2011

Completed
Last Updated

October 24, 2011

Status Verified

October 1, 2011

Enrollment Period

1.3 years

First QC Date

October 20, 2011

Last Update Submit

October 21, 2011

Conditions

Pulmonary EmbolismDeep Venous Thrombosis

Outcome Measures

Primary Outcomes (1)

  • Find a pulmonary embolism on the CT scan

    TO estimate the prevalence of PE among consecutive ICU patients receiving MV who required thoracic computed tomography (CT) with contrast agent injection, regardless of whether PE was suspected clinically.

    CT scan at the day of inclusion

Secondary Outcomes (1)

  • To find thrombus on compression ultrasound (CUS) of the four limbs

    CUS within 48 hours after the CT scan

Study Arms (1)

pulmonary embolism, deep venous thrombosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in ICU, mecanically ventilated with a CT scab with iodine injection

You may qualify if:

  • all patients requiring invasive MV and thoracic contrast-enhanced CT for any reason

You may not qualify if:

  • a diagnosis of PE before ICU admission,
  • allergy to contrast agents,
  • and age younger than 18 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of grenoble

Grenoble, 38043, France

Location

Related Publications (1)

  • Minet C, Lugosi M, Savoye PY, Menez C, Ruckly S, Bonadona A, Schwebel C, Hamidfar-Roy R, Dumanoir P, Ara-Somohano C, Ferretti GR, Timsit JF. Pulmonary embolism in mechanically ventilated patients requiring computed tomography: Prevalence, risk factors, and outcome. Crit Care Med. 2012 Dec;40(12):3202-8. doi: 10.1097/CCM.0b013e318265e461.

    PMID: 23164766DERIVED

MeSH Terms

Conditions

Pulmonary EmbolismVenous Thrombosis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesThrombosis

Study Officials

  • Jean Francois TIMSIT, PU/PH

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2011

First Posted

October 24, 2011

Study Start

December 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

October 24, 2011

Record last verified: 2011-10

Locations

FR(1)