NCT01958203

Brief 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. 1.Patients aged 18 and above.
  2. 2.Patients admitted to any of the critical care units, or the general or orthopaedic surgical wards.
  3. 3.Patients who have been in hospital more than 24 hours.
  4. 4.Caprini score \> 1 (see procedure)
  5. 5.Patients who have been admitted to a critical care unit and transferred out to a non surgical unit within 24 hours of admission.
  6. 6.Patients receiving oral anticoagulant therapy for indications other than VTE prophylaxis or treatment, such as atrial fibrillation and prosthetic heart valves.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
386

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 9, 2013

Completed
Last Updated

October 9, 2013

Status Verified

October 1, 2013

Enrollment Period

7 months

First QC Date

September 29, 2013

Last Update Submit

October 8, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of patients receiving inappropriate or inadequate VTE prophylaxis

    Case Report Form Analysis Form

    2 weeks

Secondary Outcomes (1)

  • Number of patients receiving inadequate VTE prophylaxis due to medication errors, missed doses etc.

    2 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Ghada Al Tajir, Ph.D

    Clinical Research Centre, Ministry of Health, United Arab Emirates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Clinical Research Centre

Study Record Dates

First Submitted

September 29, 2013

First Posted

October 9, 2013

Study Start

January 1, 2013

Primary Completion

August 1, 2013

Study Completion

September 1, 2013

Last Updated

October 9, 2013

Record last verified: 2013-10