Revaluation of Wells' Clinical Prediction Score of Deep Vein Thrombosis (DVT) in Inpatients With Thromboprophylaxis Treatment

Deep Vein Thrombosis Clinical Trial

— R-WITT  

Official title:

R-WITT Study : Revaluation of Wells' Clinical Prediction Score in Inpatients With Thromboprophylaxis Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03784937
• Other study ID #: 1994797v0
• Secondary ID: 2017-A02316-47
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: February 1, 2019

Study information

• Verified date: December 2018
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 415
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thromboses, Venous
• Thrombosis
• Venous Thrombosis

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalo-Universitaire de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Impact of thromboprophylaxis treatment	Compare area under curve of ROC curves of Wells' score between an inpatient population with or without thromboprophylaxis treatment	For enrollment to end of enrollment at 12 months
Secondary	Coherency of Wells' score between an doctor specialized in thrombosis and any other doctor.	Compare Area under curve for ROC curves of Wells' score between an doctor specialized in thrombosis and any other doctor.	For enrollment to end of enrollment at 12 months