NCT06539156

Brief Summary

Hospitalized patients are at high risk of venous thromboembolism (VTE), and the appropriate use of thromboprophylaxis can significantly reduce the incidence of VTE in high-risk patients. We investigated the pattern of VTE prophylaxis administration among elderly medical patients and assessed its appropriateness based on the American College of Chest Physicians (ACCP) recommendations. Methods A cross-sectional single-center study will be conducted between July 2024 and December 2024, including hospitalized (\> 48 h), (≥ 60 years), medical and surgical patients, and excluding patients receiving anticoagulant for other reason, having contraindication to thromboprophylaxis, or had VTE diagnosed within 48 h. The Padua and caprine prediction scores will be used to determine the patients' risk for VTE, and thromboprophylaxis use will be assessed against the ACCP recommendations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

July 29, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

July 29, 2024

Last Update Submit

December 24, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Padua score for medical patients

    Venous thromboembolism Risk assessment (Scores 0-3 are low risk and do not warrant prophylaxis. Scores ≥4 are high risk for VTE and subsequent complications; recommendation for thromboprophylaxis.)

    within 24 hours of ICU admission

  • Caprini score for surgical patients

    Venous thromboembolism Risk assessment (Total score of 0-1: Low risk of VTE Total score of ≥3: High/moderate risk of VTE )

    within 24 hours of ICU admission

Secondary Outcomes (3)

  • Bleeding risk assessment

    within 24 hours of ICU admission

  • Direct Anticoagulant cost

    within 24 hours of ICU admission till ICU discharge(at least 48 hours)

  • Adverse drug reaction cost

    within 24 hours of ICU admission till ICU discharge (at least 48 hours)

Study Arms (2)

Medical Patients

Other: DVT prophyllaxis

Surgical Patients

Other: DVT prophyllaxis

Interventions

VTE prophylaxis administration among patients based on the American College of Chest Physicians (ACCP) recommendations

Medical PatientsSurgical Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient records admitted to the ICU with medical or surgical causes treated with anticoagulants for DVT prophylaxis will be collected Patients already on anticoagulant therapy, had history of previous DVT, had End-stage liver disease, admitted with hemorrhage/bleeding or not prescribed DVT prophylaxis will be excluded.

You may qualify if:

  • Patient records
  • admitted to the ICU with
  • medical or surgical causes
  • recieved anticoagulants for DVT prophylaxis

You may not qualify if:

  • Patients already on anticoagulant therapy,
  • had history of previous DVT,
  • had End-stage liver disease,
  • admitted with hemorrhage/bleeding
  • not prescribed DVT prophylaxis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Teachers Hospital

Cairo, Cairo Governorate, 4270020, Egypt

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Pharmacy Associate Professor

Study Record Dates

First Submitted

July 29, 2024

First Posted

August 6, 2024

Study Start

August 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations