Deep Vein ThrombosisNCT05449808
Evaluation of Thromboprophylaxis Appropriateness in Hospitalized Medical Patients
An observational study of Deep Vein Thrombosis and Pulmonary Embolism, run by Al-Esraa University College at 1 site in Iraq.
Trial summary
Considering observational studies that suggested a relationship between acutely ill medical patients and venous thromboembolism (VTE), interventional studies with anticoagulant medications indicated a marked decline in VTE during and after hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis, Pulmonary Embolism, Venous Thromboses
- How many people
- 320 participants
- Where
- 1 siteIraq
- Study dates
- 13 Nov 2022to 1 Feb 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Baghdad medical city; general internal medicine divisions patients'
Who may be able to join
- Age ≥18 years
- Hospitalized for any cause in the internal medicine ward
- Ability to give informed consent, as informed by the physicians in charge of the patient
Who cannot join
- Expected hospital stay < 48 h
- Patients unable to give informed consent, as informed by the physicians in charge of the patient
- Patients with therapeutic anticoagulation at hospital admission
- Patients admitted for a disease requiring therapeutic anticoagulation
- Patients admitted to non-medical hospital wards
Trial locations and contacts
1 site in 1 country.
Iraq1 site, 1 recruiting
- Recruiting
EUC
Baghdad, 10011
Ali Ahmed, 07711120454, info@esraa.edu.iq
About this study
Official title: Evaluation of the Appropriateness of Venous Thromboprophylaxis in Hospitalized Medical Patients Employing the Padua Prediction Score: an Observational Study
Considering observational studies that suggested a relationship between acutely ill medical patients and venous thromboembolism (VTE), interventional studies with anticoagulant medications indicated a marked decline in VTE during and after hospitalization. Despite the therapeutic value of lowering this result, there is a low inclination to utilize anticoagulants in patients hospitalized for acute medical diseases. This observational research aims to assess the appropriateness of venous thromboprophylaxis offered to patients admitted to internal medicine wards.
Read the detailed description
Epidemiological studies have shown a significant prevalence of thromboembolism in patients admitted to medical wards.
Based on this, various clinical studies using anticoagulants such as unfractionated heparin (UFH), low-molecular-weight heparin (LMWH), and fondaparinux to prevent thromboembolism have been conducted in patients hospitalized for acute medical illness.
Interventional studies have repeatedly shown that anticoagulant prophylaxis lowers the incidence of deep venous thrombosis (DVT), pulmonary embolism (PE), and DVT-related mortality.
These findings led to recommendations to employ anticoagulant prophylaxis in patients hospitalized for acute medical disease; yet, anticoagulant prophylaxis is often underutilized in-hospital medical wards.
This study's primary objective is to assess the adequacy of venous thromboprophylaxis delivered to medical inpatients who need pharmacologic intervention in accordance with the American College of Chest Physicians (ACCP) guideline using the Padua prediction score.
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolism, Venous Thromboses
- Keywords
- Padua prediction score, Pulmonary Embolism, Deep Vein Thrombosis, Venous Thromboses, Acute medical illness
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism
What is being measured
The primary outcome is the main question the study is designed to answer.
Appropriateness of venous thromboprophylaxis
The primary outcome of this study is to evaluate the appropriateness of venous thromboprophylaxis administered to medical inpatients who need pharmacologic interventions according to the American College of Chest Physicians (ACCP) 2012 guidelines and its second update in 2021.
Measured: August - December 2022
Secondary outcomes (1)
Reasons for insufficient venous thromboprophylaxis
The secondary purpose is to explore some significant reasons for insufficient venous thromboprophylaxis in various patients, such as prescription errors and administration mistakes.
Measured: August - December 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start13 Nov 2022 (estimated)
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Deep Vein ThrombosisStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Esraa University College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laith G. Shareef, Al-Esraa University College
- Investigators
- Khulood M. Alsaraf, ASST PROF, Study chair, Al-Esraa University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449808
- Sponsor's protocol ID
- Venous thromboprophylaxis
- Status last verified
- Oct 2022
- First submitted
- 5 Jul 2022
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Haas SK. Venous thromboembolic risk and its prevention in hospitalized medical patients. Semin Thromb Hemost. 2002 Dec;28(6):577-84. doi: 10.1055/s-2002-36702.
PubMed 12536351Barbar S, Noventa F, Rossetto V, Ferrari A, Brandolin B, Perlati M, De Bon E, Tormene D, Pagnan A, Prandoni P. A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism: the Padua Prediction Score. J Thromb Haemost. 2010 Nov;8(11):2450-7. doi: 10.1111/j.1538-7836.2010.04044.x.
PubMed 20738765
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Appropriateness of Venous Thromboprophylaxis in Hospitalized Medical Patients Employing the Padua Prediction Score: an Observational Study
- ClinicalTrials.gov ID
- NCT05449808
- Acronym / sponsor ID
- Venous thromboprophylaxis
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolism, Venous Thromboses
- Keywords
- Padua prediction score, Pulmonary Embolism, Deep Vein Thrombosis, Venous Thromboses, Acute medical illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Al-Esraa University CollegeUniversity, hospital or other
- Study start
- 13 Nov 2022 (estimated)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 8 Jul 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.
Considering observational studies that suggested a relationship between acutely ill medical patients and venous thromboembolism (VTE), interventional studies with anticoagulant medications indicated a marked decline in VTE during and after hospitalization. Despite the therapeutic value of lowering this result, there is a low inclination to utilize anticoagulants in patients hospitalized for acute medical diseases. This observational research aims to assess the appropriateness of venous thromboprophylaxis offered to patients admitted to internal medicine wards.
Detailed description
Epidemiological studies have shown a significant prevalence of thromboembolism in patients admitted to medical wards.
Based on this, various clinical studies using anticoagulants such as unfractionated heparin (UFH), low-molecular-weight heparin (LMWH), and fondaparinux to prevent thromboembolism have been conducted in patients hospitalized for acute medical illness.
Interventional studies have repeatedly shown that anticoagulant prophylaxis lowers the incidence of deep venous thrombosis (DVT), pulmonary embolism (PE), and DVT-related mortality.
These findings led to recommendations to employ anticoagulant prophylaxis in patients hospitalized for acute medical disease; yet, anticoagulant prophylaxis is often underutilized in-hospital medical wards.
This study's primary objective is to assess the adequacy of venous thromboprophylaxis delivered to medical inpatients who need pharmacologic intervention in accordance with the American College of Chest Physicians (ACCP) guideline using the Padua prediction score.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Baghdad medical city; general internal medicine divisions patients'
Key inclusion criteria (3 listed)
- Age ≥18 years
- Hospitalized for any cause in the internal medicine ward
- Ability to give informed consent, as informed by the physicians in charge of the patient
Key exclusion criteria (5 listed)
- Expected hospital stay < 48 h
- Patients unable to give informed consent, as informed by the physicians in charge of the patient
- Patients with therapeutic anticoagulation at hospital admission
- Patients admitted for a disease requiring therapeutic anticoagulation
- Patients admitted to non-medical hospital wards
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
Appropriateness of venous thromboprophylaxis
Time frame: August - December 2022
The primary outcome of this study is to evaluate the appropriateness of venous thromboprophylaxis administered to medical inpatients who need pharmacologic interventions according to the American College of Chest Physicians (ACCP) 2012 guidelines and its second update in 2021.
1 secondary outcome
Reasons for insufficient venous thromboprophylaxis
Time frame: August - December 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Background: PubMed 12536351Haas SK. Venous thromboembolic risk and its prevention in hospitalized medical patients. Semin Thromb Hemost. 2002 Dec;28(6):577-84. doi: 10.1055/s-2002-36702.
- Background: PubMed 20738765Barbar S, Noventa F, Rossetto V, Ferrari A, Brandolin B, Perlati M, De Bon E, Tormene D, Pagnan A, Prandoni P. A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism: the Padua Prediction Score. J Thromb Haemost. 2010 Nov;8(11):2450-7. doi: 10.1111/j.1538-7836.2010.04044.x.
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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.
Khulood M. Alsaraf, ASST PROF study chair
Al-Esraa University College
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 Deep Vein Thrombosis and Pulmonary Embolism, run by Al-Esraa University College at 1 site in Iraq.
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 5 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 24 Oct 2022. 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 Iraq. 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 Laith G. Shareef, F.I.B.M.S. (009647702884263, laith-shareef@esraa.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appropriateness of venous thromboprophylaxis (time frame: August - December 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05449808, which also lists 2 linked publications.
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 24 Oct 2022; AzTrials last refreshed its copy on 8 Nov 2026.