Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-01-07 @ 7:03 AM
Study NCT ID:
NCT01958203
Status:
COMPLETED
Last Update Posted:
2013-10-09
First Post:
2013-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Venous Thromboembolism Prophylaxis in a Tertiary UAE Hospital: Comparison of Clinical Practice Guidelines.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 386}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-08', 'studyFirstSubmitDate': '2013-09-29', 'studyFirstSubmitQcDate': '2013-10-08', 'lastUpdatePostDateStruct': {'date': '2013-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients receiving inappropriate or inadequate VTE prophylaxis', 'timeFrame': '2 weeks', 'description': 'Case Report Form Analysis Form'}], 'secondaryOutcomes': [{'measure': 'Number of patients receiving inadequate VTE prophylaxis due to medication errors, missed doses etc.', 'timeFrame': '2 weeks', 'description': 'Case Report Form Analysis Form'}]}, 'conditionsModule': {'conditions': ['Venous Thromboembolism']}, 'descriptionModule': {'briefSummary': "Study Title:Assessment of Adherence to Guidelines for Thromboprophylaxis in a Tertiary United Arab Emirates (UAE) hospital\n\nStudy Site: Al Qassimi Hospital, United Arab Emirates\n\nStudy Objectives:\n\nThe 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.\n\nThe secondary objective is to:\n\n1.Identify some causes of inadequate VTE prophylaxis in different patient populations, such as prescribing problems and errors at the level of administration.\n\nStudy Design: Cross sectional retrospective observational study\n\nSample size: Approximately 400\n\nStudy Population:\n\nInclusion criteria\n\nPatients who meet the following criteria will be included:\n\n1. Patients aged 18 and above.\n2. Patients admitted to any of the critical care units, or the general or orthopaedic surgical wards.\n3. Patients who have been in hospital more than 24 hours.\n4. Caprini score \\> 1 (see procedure)\n\nExclusion criteria\n\nPatients with any of the following criteria will be excluded:\n\n1. Patients who have been admitted to a critical care unit and transferred out to a non surgical unit within 24 hours of admission.\n2. Patients receiving oral anticoagulant therapy for indications other than VTE prophylaxis or treatment, such as atrial fibrillation and prosthetic heart valves.\n\nStudy Outcome Measurements:\n\nThe 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.\n\nSecondary outcome measures are to identify whether there is inadequate VTE prophylaxis because of medication errors such as missed doses or wrong doses given.\n\nStudy Duration: 4 months\n\nStatistical 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged 18 and above.\n2. Patients admitted to any of the critical care units, or the general or orthopaedic surgical wards.\n3. Patients who have been in hospital more than 24 hours.\n4. Caprini score \\> 1 (see procedure)\n\nExclusion Criteria:\n\n1. Patients who have been admitted to a critical care unit and transferred out to a non surgical unit within 24 hours of admission.\n2. Patients receiving oral anticoagulant therapy for indications other than VTE prophylaxis or treatment, such as atrial fibrillation and prosthetic heart valves.'}, 'identificationModule': {'nctId': 'NCT01958203', 'acronym': 'VTE', 'briefTitle': 'Venous Thromboembolism Prophylaxis in a Tertiary UAE Hospital: Comparison of Clinical Practice Guidelines.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ministry of Health, United Arab Emirates'}, 'officialTitle': 'Venous Thromboembolism Prophylaxis in a Tertiary UAE Hospital: Comparison of Clinical Practice Guidelines.', 'orgStudyIdInfo': {'id': '122012-11'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ghada Al Tajir, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research Centre, Ministry of Health, United Arab Emirates'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ministry of Health, United Arab Emirates', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Clinical Research Centre', 'investigatorFullName': 'Dr. Ghada Al Tajir', 'investigatorAffiliation': 'Ministry of Health, United Arab Emirates'}}}}