Venous Thromboembolism Prophylaxis in a Tertiary UAE Hospital: Comparison of Clinical Practice Guidelines.

Venous Thromboembolism Clinical Trial

— VTE  

Official title:

Venous Thromboembolism Prophylaxis in a Tertiary UAE Hospital: Comparison of Clinical Practice Guidelines.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01958203
• Other study ID #: 122012-11
• Status: Completed
• Phase: N/A
• First received: September 29, 2013
• Last updated: October 8, 2013
• Start date: January 2013
• Est. completion date: September 2013

Study information

• Verified date: October 2013
• Source: Ministry of Health, United Arab Emirates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Arab Emirates: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 386
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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:

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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health, United Arab Emirates

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients receiving inappropriate or inadequate VTE prophylaxis	Case Report Form Analysis Form	2 weeks	No
Secondary	Number of patients receiving inadequate VTE prophylaxis due to medication errors, missed doses etc.	Case Report Form Analysis Form	2 weeks	No