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.
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:
- 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)
Exclusion criteria
Patients with any of the following criteria will be excluded:
- 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.
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.
- Conditions
- Venous Thromboembolism
- Medical subject headings
- Venous Thromboembolism
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients receiving inappropriate or inadequate VTE prophylaxis
Case Report Form Analysis Form
Measured: 2 weeks
Secondary outcomes (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.
- First posted9 Oct 2013 (estimated)
- Study startJan 2013
- Primary completionAug 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, United Arab Emirates
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Ghada Al Tajir, Ministry of Health, United Arab Emirates
- Investigators
- Ghada Al Tajir, Ph.D, Principal investigator, Clinical Research Centre, Ministry of Health, United Arab Emirates
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Thromboembolism Prophylaxis in a Tertiary UAE Hospital: Comparison of Clinical Practice Guidelines.
- ClinicalTrials.gov ID
- NCT01958203
- Acronym / sponsor ID
- VTE / 122012-11
- Conditions
- Venous Thromboembolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Ministry of Health, United Arab EmiratesOther government
- Study start
- Jan 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 9 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)
Exclusion criteria
Patients with any of the following criteria will be excluded:
- 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.
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.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients receiving inappropriate or inadequate VTE prophylaxis
Time frame: 2 weeks
Case Report Form Analysis Form
1 secondary outcome
Number of patients receiving inadequate VTE prophylaxis due to medication errors, missed doses etc.
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ghada Al Tajir, Ph.D principal investigator
Clinical Research Centre, Ministry of Health, United Arab Emirates
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.