MTE: Incidence and Risk Factors of Venous Thrombosis of the Lower Limbs After Hospitalization in Medical Patients at Risk

Sponsor
University of Monastir (Other)
Overall Status
Recruiting
CT.gov ID
NCT05512923
Collaborator
(none)
2,000
1
25.5
78.4

Study Details

Study Description

Brief Summary

In Tunisia, the available data are limited regarding the incidence of venous thrombosis of the lower limbs (TVMI) post-hospitalization, whether symptomatic or subclinical. The thromboprophylactic strategy will certainly depend on the incidence of this complication and its severity. In this study, we performed a systematic screening for TVMI in a well-characterized cohort of patients discharged after hospitalization >48h for an acute medical condition.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a prospective follow-up of patients after hospitalization for more than 48 hours 6 weeks after discharge. The study must be approved by the ethics committee and all patients will have given their written informed consent.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Incidence and Risk Factors of Venous Thrombosis of the Lower Limbs After Hospitalization in Medical Patients at Risk
    Actual Study Start Date :
    Aug 15, 2021
    Anticipated Primary Completion Date :
    Aug 15, 2023
    Anticipated Study Completion Date :
    Sep 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. presence of any symptoms suggestive of venous or arterial thromboembolic disease [Day7]

      The first contact took place on day 7 after discharge from the hospital and is done by telephone. Patients will be asked about the presence of any symptoms suggestive of venous or arterial thromboembolic disease: angina, dyspnoea, peripheral edema, pain in the lower limbs or any other new symptom

    Secondary Outcome Measures

    1. presence of any symptoms suggestive of venous or arterial thromboembolic disease [day45]

      On D45, the patient will be seen again in the hospital. On the same day, the same symptoms will be sought and a second venous Doppler ultrasound of the lower limbs will be performed. If PE is suspected, a pulmonary CT angiography will also be performed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 90 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Eligible patients included adults aged at least 40 years old, hospitalized for more than 48 hours for an acute medical illness (i.e. heart failure, active cancer, acute ischemic stroke, infectious diseases, inflammatory disease and respiratory failure acute), patients at risk of MIVT due to moderate or severe immobility, history of thrombophilia (factor C or S deficiency, etc.), body mass index of 30 kg/m2.
    Exclusion Criteria:
    • patients who required intensive care, patients with cognitive impairment, patients admitted for SARS-CoV-2 infection or patients with a hospital stay <2 days, patients with a pre-existing reason for anticoagulation (therapeutic), such as atrial fibrillation or ETD and patients in whom MIVT is discovered on first ultrasound examination upon discharge from hospital.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nouira Monastir Tunisia 5060

    Sponsors and Collaborators

    • University of Monastir

    Investigators

    • Study Director: nouira semir, Pr, CHU Fattouma Bourguiba Monastir, service des urgences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pr. Semir Nouira, Chef of Emergency Deparment, University of Monastir
    ClinicalTrials.gov Identifier:
    NCT05512923
    Other Study ID Numbers:
    • MTE 2022
    First Posted:
    Aug 23, 2022
    Last Update Posted:
    Aug 23, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Pr. Semir Nouira, Chef of Emergency Deparment, University of Monastir
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 23, 2022