NCT03784937

Brief Summary

This study aimed (1) revaluating the efficacy of the Wells' clinical prediction score for an inpatient population; and the weight of the presence of thromboprophylaxis treatment on the score, and (2) evaluating the correlation of a risk stratification established between a physician specialised in thrombosis and any other doctor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
415

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

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

February 1, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 24, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2019

Completed
Last Updated

December 1, 2025

Status Verified

December 1, 2018

Enrollment Period

1.1 years

First QC Date

December 7, 2018

Last Update Submit

November 24, 2025

Conditions

Keywords

Wells Clinical scoreThromboprophylaxis

Outcome Measures

Primary Outcomes (1)

  • Performance of the Wells Clinical prediction score

    Analyse area under the curve (AUC) of the Wells' score ROC (Receiver Operating Characteristic) curve for an inpatient population

    For enrollment to end of enrollment at 12 months

Secondary Outcomes (2)

  • Impact of thromboprophylaxis treatment

    For enrollment to end of enrollment at 12 months

  • Coherency of Wells' score between an doctor specialized in thrombosis and any other doctor.

    For enrollment to end of enrollment at 12 months

Interventions

Doppler ultrasoundDIAGNOSTIC_TEST

Each patient received Doppler ultrasound for research of DVT, no matter the risk stratification.

Eligibility Criteria

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

Any patient adressed to an Vascular Medicine unit for a clinical suspicion of DVT, with risk stratification throught the modified Wells score by the referent doctor.

You may qualify if:

  • Any patient addressed to an Vascular Medicine unit for a clinical suspicion of DVT, with risk stratification through the modified Wells score by the referent doctor.

You may not qualify if:

  • Patient addressed to our Vascular Medicine unit for any other reason.
  • Patient addressed to our Vascular Medicine unit for DVT detection to help in a pulmonary embolism suspicion.
  • Age under 18 yo
  • Patients unable to express their informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalo-Universitaire de Nîmes

Nîmes, 30000, France

Location

Related Publications (1)

  • Trihan JE, Adam M, Jidal S, Aichoun I, Coudray S, Laurent J, Chaussavoine L, Chausserie S, Guillaumat J, Laneelle D, Perez-Martin A. Performance of the Wells score in predicting deep vein thrombosis in medical and surgical hospitalized patients with or without thromboprophylaxis: The R-WITT study. Vasc Med. 2021 Jun;26(3):288-296. doi: 10.1177/1358863X21994672. Epub 2021 Mar 22.

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Ultrasonography, Doppler

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

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

Study Record Dates

First Submitted

December 7, 2018

First Posted

December 24, 2018

Study Start

February 1, 2018

Primary Completion

March 4, 2019

Study Completion

March 4, 2019

Last Updated

December 1, 2025

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations