DVTNCT06539156
Prescribing Appropriateness of Thrombo-prophylaxis in Intensive Care Unit of Tertiary Hospital
An observational study of DVT, run by Ain Shams University at 1 site in Egypt.
Trial summary
Hospitalized patients are at high risk of venous thromboembolism (VTE), and the appropriate use of thromboprophylaxis can significantly reduce the incidence of VTE in high-risk patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DVT
- What is being tested?
- DVT prophyllaxis
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 1 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient records admitted to the ICU with medical or surgical causes treated with anticoagulants for DVT prophylaxis will be collected Patients already on anticoagulant therapy, had history of previous DVT, had End-stage liver disease, admitted with hemorrhage/bleeding or not prescribed DVT prophylaxis will be excluded.
Who may be able to join
- Patient records
- admitted to the ICU with
- medical or surgical causes
- recieved anticoagulants for DVT prophylaxis
Who cannot join
- Patients already on anticoagulant therapy,
- had history of previous DVT,
- had End-stage liver disease,
- admitted with hemorrhage/bleeding
- not prescribed DVT prophylaxis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pattern of Prescribing Anticoagulants As DVT Prophylaxis in Intensive Care Unit of Tertiary Hospital
Hospitalized patients are at high risk of venous thromboembolism (VTE), and the appropriate use of thromboprophylaxis can significantly reduce the incidence of VTE in high-risk patients. We investigated the pattern of VTE prophylaxis administration among elderly medical patients and assessed its appropriateness based on the American College of Chest Physicians (ACCP) recommendations. Methods A cross-sectional single-center study will be conducted between July 2024 and December 2024, including hospitalized (> 48 h), (≥ 60 years), medical and surgical patients, and excluding patients receiving anticoagulant for other reason, having contraindication to thromboprophylaxis, or had VTE diagnosed within 48 h. The Padua and caprine prediction scores will be used to determine the patients' risk for VTE, and thromboprophylaxis use will be assessed against the ACCP recommendations.
- Conditions
- DVT
- Being tested
- DVT prophyllaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DVT prophyllaxisOther
VTE prophylaxis administration among patients based on the American College of Chest Physicians (ACCP) recommendations
| Study group | Role | What they receive |
|---|---|---|
| Medical Patients | Not described Receives: Other: DVT prophyllaxis | |
| Surgical Patients | Not described Receives: Other: DVT prophyllaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Padua score for medical patients
Venous thromboembolism Risk assessment (Scores 0-3 are low risk and do not warrant prophylaxis. Scores ≥4 are high risk for VTE and subsequent complications; recommendation for thromboprophylaxis.)
Measured: within 24 hours of ICU admission
Caprini score for surgical patients
Venous thromboembolism Risk assessment (Total score of 0-1: Low risk of VTE Total score of ≥3: High/moderate risk of VTE )
Measured: within 24 hours of ICU admission
Secondary outcomes (3)
Bleeding risk assessment
Measured: within 24 hours of ICU admission
Direct Anticoagulant cost
sum of costs related to the anticoagulant administration for DVT Prophylaxis
Measured: within 24 hours of ICU admission till ICU discharge(at least 48 hours)
Adverse drug reaction cost
sum of costs related to the Adverse drug reaction for DVT Prophylaxis
Measured: within 24 hours of ICU admission till ICU discharge (at least 48 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Aug 2024
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DVTStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Egyptian Chinese University, Teachers Hospital
- Responsible party
- Principal investigator, Sarah Sabry Hashem, Egyptian Chinese University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539156
- Sponsor's protocol ID
- 2887764466
- Status last verified
- Dec 2024
- First submitted
- 29 Jul 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Prescribing Anticoagulants As DVT Prophylaxis in Intensive Care Unit of Tertiary Hospital
- ClinicalTrials.gov ID
- NCT06539156
- Acronym / sponsor ID
- 2887764466
- Conditions
- DVT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Egyptian Chinese University, Teachers Hospital
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 6 Aug 2024 (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.
Hospitalized patients are at high risk of venous thromboembolism (VTE), and the appropriate use of thromboprophylaxis can significantly reduce the incidence of VTE in high-risk patients. We investigated the pattern of VTE prophylaxis administration among elderly medical patients and assessed its appropriateness based on the American College of Chest Physicians (ACCP) recommendations. Methods A cross-sectional single-center study will be conducted between July 2024 and December 2024, including hospitalized (> 48 h), (≥ 60 years), medical and surgical patients, and excluding patients receiving anticoagulant for other reason, having contraindication to thromboprophylaxis, or had VTE diagnosed within 48 h. The Padua and caprine prediction scores will be used to determine the patients' risk for VTE, and thromboprophylaxis use will be assessed against the ACCP recommendations.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical Patients | – | Other: DVT prophyllaxis |
| Surgical Patients | – | Other: DVT prophyllaxis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient records admitted to the ICU with medical or surgical causes treated with anticoagulants for DVT prophylaxis will be collected Patients already on anticoagulant therapy, had history of previous DVT, had End-stage liver disease, admitted with hemorrhage/bleeding or not prescribed DVT prophylaxis will be excluded.
Key inclusion criteria (4 listed)
- Patient records
- admitted to the ICU with
- medical or surgical causes
- recieved anticoagulants for DVT prophylaxis
Key exclusion criteria (5 listed)
- Patients already on anticoagulant therapy,
- had history of previous DVT,
- had End-stage liver disease,
- admitted with hemorrhage/bleeding
- not prescribed DVT prophylaxis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DVT prophyllaxisVTE prophylaxis administration among patients based on the American College of Chest Physicians (ACCP) recommendations | Other | Medical Patients, Surgical Patients |
Primary outcome
Padua score for medical patients
Time frame: within 24 hours of ICU admission
Venous thromboembolism Risk assessment (Scores 0-3 are low risk and do not warrant prophylaxis. Scores ≥4 are high risk for VTE and subsequent complications; recommendation for thromboprophylaxis.)
Caprini score for surgical patients
Time frame: within 24 hours of ICU admission
Venous thromboembolism Risk assessment (Total score of 0-1: Low risk of VTE Total score of ≥3: High/moderate risk of VTE )
3 secondary outcomes
Bleeding risk assessment
Time frame: within 24 hours of ICU admission
Direct Anticoagulant cost
Time frame: within 24 hours of ICU admission till ICU discharge(at least 48 hours)
Adverse drug reaction cost
Time frame: within 24 hours of ICU admission till ICU discharge (at least 48 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 DVT, run by Ain Shams University at 1 site in Egypt.
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 4 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: finished, as of the sponsor's last update on 27 Dec 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Padua score for medical patients (time frame: within 24 hours of ICU admission). The study lists 2 primary outcomes in all. 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 27 Dec 2024.