- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06539156
Prescribing Appropriateness of Thrombo-prophylaxis in Intensive Care Unit of Tertiary Hospital
December 24, 2024 updated by: Sarah Sabry Hashem, Ain Shams University
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Cairo, Egypt, 4270020
- Teachers Hospital
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-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
Patient records
- admitted to the ICU with
- medical or surgical causes
- recieved anticoagulants for DVT prophylaxis
Exclusion Criteria:
- Patients already on anticoagulant therapy,
- had history of previous DVT,
- had End-stage liver disease,
- admitted with hemorrhage/bleeding
- not prescribed DVT prophylaxis
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Surgical Patients
|
VTE prophylaxis administration among patients based on the American College of Chest Physicians (ACCP) recommendations
|
|
Medical Patients
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VTE prophylaxis administration among patients based on the American College of Chest Physicians (ACCP) recommendations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.)
|
within 24 hours of ICU admission
|
|
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 )
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within 24 hours of ICU admission
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bleeding risk assessment
Time Frame: within 24 hours of ICU admission
|
within 24 hours of ICU admission
|
|
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Direct Anticoagulant cost
Time Frame: within 24 hours of ICU admission till ICU discharge(at least 48 hours)
|
sum of costs related to the anticoagulant administration for DVT Prophylaxis
|
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)
|
sum of costs related to the Adverse drug reaction for DVT Prophylaxis
|
within 24 hours of ICU admission till ICU discharge (at least 48 hours)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 1, 2024
Primary Completion (Actual)
December 1, 2024
Study Completion (Actual)
December 1, 2024
Study Registration Dates
First Submitted
July 29, 2024
First Submitted That Met QC Criteria
August 2, 2024
First Posted (Actual)
August 6, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 24, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 2887764466
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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