Patients Hospitalized for More Than 48 HoursMTENCT05512923
Incidence and Risk Factors of Venous Thrombosis of the Lower Limbs After Hospitalization in Medical Patients at Risk
An observational study of Patients Hospitalized for More Than 48 Hours and Acute Medical Illness, run by University of Monastir at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Patients Hospitalized for More Than 48 Hours, Acute Medical Illness
- How many people
- 2,000 participants
- Where
- 1 siteTunisia
- Study dates
- 15 Aug 2021to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients included adults aged at least 40 years old, hospitalized for more than 48 hours for an acute medical illness
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Nouira
Monastir, 5060
Nouira Semir, professor, 73106046, semir.nouira@rns.tn
bel hadj ali khaoula, MD, 73106046
About this study
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.
Read the 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.
- Keywords
- MTE
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of any symptoms suggestive of venous or arterial thromboembolic disease
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
Measured: Day7
Secondary outcomes (1)
presence of any symptoms suggestive of venous or arterial thromboembolic disease
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.
Measured: day45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start15 Aug 2021
- Primary completion15 Aug 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Hospitalized for More Than 48 HoursStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- nouira semir, Pr, Study director, CHU Fattouma Bourguiba Monastir, service des urgences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512923
- Sponsor's protocol ID
- MTE 2022
- Acronym
- MTE
- Status last verified
- Mar 2024
- First submitted
- 20 Aug 2022
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factors of Venous Thrombosis of the Lower Limbs After Hospitalization in Medical Patients at Risk
- ClinicalTrials.gov ID
- NCT05512923
- Acronym / sponsor ID
- MTE / MTE 2022
- Keywords
- MTE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 15 Aug 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 23 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients included adults aged at least 40 years old, hospitalized for more than 48 hours for an acute medical illness
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
presence of any symptoms suggestive of venous or arterial thromboembolic disease
Time frame: day45
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
nouira semir, Pr study director
CHU Fattouma Bourguiba Monastir, service des urgences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Hospitalized for More Than 48 Hours and Acute Medical Illness, run by University of Monastir at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact nouira semir, Pr (73106000 ext. 216, semir.nouira@rns.tn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of any symptoms suggestive of venous or arterial thromboembolic disease (time frame: Day7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.