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Venous ThromboembolismVTENCT01958203

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

An observational study of Venous Thromboembolism, run by Ministry of Health, United Arab Emirates.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Thromboembolism
How many people
386 participants
Where
No sites listed yet
Study dates
Jan 2013to Sep 2013
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: The targe sample is paients in critical care wards and orthopaedic surgery patients. All patients will be screened at discharge. Those who fulfill the inclusion/exclusion criteria will go on to have a thromboembolism risk assessment using the CapriniRisk Assessment Model. Those who have a score > 1 will be included for assessment of their VTE prophylaxis (from medical records). Approximately 60 patients are admitted into critical care units and 40 general and orthopaedic surgical patients are admitted to the surgical wards per month, giving a total sample of around 400 patients.

Who may be able to join

  • Patients aged 18 and above.
  • Patients admitted to any of the critical care units, or the general or orthopaedic surgical wards.
  • Patients who have been in hospital more than 24 hours.
  • Caprini score > 1 (see procedure)

Who cannot join

  • Patients who have been admitted to a critical care unit and transferred out to a non surgical unit within 24 hours of admission.
  • Patients receiving oral anticoagulant therapy for indications other than VTE prophylaxis or treatment, such as atrial fibrillation and prosthetic heart valves.

About this study

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

Read more

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.

Medical subject headings
Venous Thromboembolism

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients receiving inappropriate or inadequate VTE prophylaxis

    Case Report Form Analysis Form

    Measured: 2 weeks

Secondary outcomes (1)
  1. Number of patients receiving inadequate VTE prophylaxis due to medication errors, missed doses etc.

    Case Report Form Analysis Form

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionAug 2013
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Retrospective
Enrolment
386 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01958203
Sponsor's protocol ID
122012-11
Acronym
VTE
Status last verified
Oct 2013
First submitted
29 Sep 2013
Last updated
9 Oct 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Venous Thromboembolism, run by Ministry of Health, United Arab Emirates.

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 2 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 9 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

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?

Number of patients receiving inappropriate or inadequate VTE prophylaxis (time frame: 2 weeks). 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 9 Oct 2013.

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