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NCT Number: NCT03812848

Clinical Pharmacist-led Inpatient Anticoagulation Stewardship Program

This study aims at evaluating the implementation of clinical-pharmacist-led anticoagulation stewardship program in Egyptian tertiary hospital to promote a culture of safety around anticoagulants.

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Key information

Conditions

Deep Vein Thrombosis Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Embolism and Thrombosis Heart Diseases Mitral Valve Disease Pathologic Processes Pathological Conditions, Signs and Symptoms Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Pharmacy, Ain Shams University

Cairo, 11566, Egypt

About this study

One of the high-alert medication categories that may cause significant patient harm if not used correctly is anticoagulants. It is not clear if medication errors are more common with this category in specific compared to other medication categories, but the ramifications of a medication error with the use of anticoagulation agents is without a doubt detrimental to the patient's health and more serious than most of other drug categories.

This prospective study evaluates the impact of implementing an anticoagulation stewardship program, led by clinical pharmacists, on anticoagulation therapy outcomes during patient hospitalization by the percent of medication errors reduction, percent of adverse drug events reduction, and percent of evidence-based guidelines compliance improvement.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All hospitalized patients on therapeutic anticoagulant medication during their hospitalization period.

Exclusion criteria

  • Patients whose age is less than 18 years old.
  • Patients who were admitted for less than 24 hours for patient on parenteral anticoagulants and less than 48 hours for patient on warfarin.
  • Patients already admitted for bleeding or thrombosis.
  • Malignancy patients.

Treatment and study plan

Anticoagulation Stewardship Program

Other

A clinical-pharmacist led anticoagulation stewardship program that includes:

  • Warfarin monitoring and dosing protocol. 1a.Warfarin initial dosing algorithm. 1b.Recommended International normalized ration (INR) target and duration of Warfarin therapy by indication.

1c.Warfarin dosage adjustment algorithms.

1d.Management of high INR values. 2-Heparin weight-based protocol. 3-Perioperative anticoagulation use protocol. 4-Policies that address baseline and ongoing laboratory monitoring for anticoagulants.

5-Protocol for Heparin Induced Thrombocytopenia(HIT) management. 6-Anticoagulation reversal protocol. 7-Booklet for anticoagulant drugs and all of previously prepared protocols. 8-Education programs regarding anticoagulation's therapy for health care team dealing with anticoagulation and patients.

Primary outcomes

  1. Percent of medication errors change

    Time frame: one year and half

    Detect the medication error according to (National Coordinating Council for Medication Errors Reporting and Prevention NCC MERP) Index for Categorizing Medication Errors using NCC MERP Index for Categorizing Medication Errors Algorithm.

  2. percent of adverse drug events change

    Time frame: one year and half

    Detect bleeding and thrombotic-related adverse drug events

  3. Percent of evidence-based guidelines compliance improvement

    Time frame: one year and half

    Detect health care providers' adherence to evidence-based guidelines for anticoagulation therapy.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Implementation of Clinical Pharmacist-led Inpatient Anticoagulation Stewardship Program in An Egyptian Tertiary Care Hospital

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jan 23, 2019
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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