Venous Thromboembolism Clinical Trial
Official title:
Venous Thromboembolism Prophylaxis in a Tertiary UAE Hospital: Comparison of Clinical Practice Guidelines.
Study Title:Assessment of Adherence to Guidelines for Thromboprophylaxis in a Tertiary
United Arab Emirates (UAE) hospital
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.
n/a
Time Perspective: Retrospective
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