Venous Thromboembolism Prophylaxis in a Tertiary UAE Hospital: Comparison of Clinical Practice Guidelines.
NCT ID: NCT01958203
Last Updated: 2013-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
386 participants
OBSERVATIONAL
2013-01-31
2013-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Study Site: Al Qassimi Hospital, United Arab Emirates
Study Objectives:
The primary objective of this study is assessment of appropriateness of VTE prophylaxis administered to critically ill and surgical patients for whom pharmacologic treatment is indicated according to the American College of Chest Physicians (ACCP) 2012 guidelines.
The secondary objective is to:
1.Identify some causes of inadequate VTE prophylaxis in different patient populations, such as prescribing problems and errors at the level of administration.
Study Design: Cross sectional retrospective observational study
Sample size: Approximately 400
Study Population:
Inclusion criteria
Patients who meet the following criteria will be included:
1. Patients aged 18 and above.
2. Patients admitted to any of the critical care units, or the general or orthopaedic surgical wards.
3. Patients who have been in hospital more than 24 hours.
4. Caprini score \> 1 (see procedure)
Exclusion criteria
Patients with any of the following criteria will be excluded:
1. Patients who have been admitted to a critical care unit and transferred out to a non surgical unit within 24 hours of admission.
2. Patients receiving oral anticoagulant therapy for indications other than VTE prophylaxis or treatment, such as atrial fibrillation and prosthetic heart valves.
Study Outcome Measurements:
The main outcome measure of interest is to determine the proportion of patients who have received inappropriate or inadequate VTE prophylaxis considering their calculated risk factor compared to the recommended prophylactic measures for that risk.
Secondary outcome measures are to identify whether there is inadequate VTE prophylaxis because of medication errors such as missed doses or wrong doses given.
Study Duration: 4 months
Statistical Analysis Data was entered into Microsoft Excel® and subsequently checked to ensure accurate data entry and correct any errors. It was subsequently exported into SPSS version 20 where it will be analysed.Quantitative data such as age was expressed mean (± standard deviation). Categorical data such as gender, risk factors for bleeding, type of mechanical and pharmacologic prophylaxis, missed doses and wrong doses were expressed as number and percentage of population.The student's t-test was used to analyse parametric data. The Pearson Chi-Square Test and Wilcoxon Rank sum test were used to analyse non parametric data. Simple and multiple logistic regression analysis was done to identify factors that are associated with inappropriate VTE prophylaxis. Factors that were included in the analysis included: age, type of admission (medical or surgical), area of admission (critical care, general surgery, orthopaedic surgery), Caprini score, and inappropriate VTE prophylaxis as the outcome. A p-value of less than 0.05 was be considered statistically significant.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RETROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients admitted to any of the critical care units, or the general or orthopaedic surgical wards.
3. Patients who have been in hospital more than 24 hours.
4. Caprini score \> 1 (see procedure)
Exclusion Criteria
2. Patients receiving oral anticoagulant therapy for indications other than VTE prophylaxis or treatment, such as atrial fibrillation and prosthetic heart valves.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ministry of Health, United Arab Emirates
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Ghada Al Tajir
Director of Clinical Research Centre
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ghada Al Tajir, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Clinical Research Centre, Ministry of Health, United Arab Emirates
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
122012-11
Identifier Type: -
Identifier Source: org_study_id