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

March 14, 2024 updated by: Pr. Semir Nouira, University of Monastir
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Tunisia
      • Monastir, Tunisia, 5060
        • Recruiting
        • Nouira
        • Contact:
          • bel hadj ali khaoula, MD
          • Phone Number: 73106046
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Eligible patients included adults aged at least 40 years old, hospitalized for more than 48 hours for an acute medical illness

Description

Inclusion Criteria:

  • 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:

  • hospitalised for less than 48
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
presence of any symptoms suggestive of venous or arterial thromboembolic disease
Time Frame: 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
Day7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
presence of any symptoms suggestive of venous or arterial thromboembolic disease
Time Frame: 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.
day45

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Monastir

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2021

Primary Completion (Estimated)

August 15, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

August 20, 2022

First Submitted That Met QC Criteria

August 22, 2022

First Posted (Actual)

August 23, 2022

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTE 2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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