Intentional Warfarin Sodium OverdoseNCT01972971
To Establish a Novel Prototype of Clinical Pharmacy Services by Warfarin Consultation in a Pharmacist Clinic
A study testing patient education in people with Intentional Warfarin Sodium Overdose, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Warfarin, the major oral anticoagulant currently available in Taiwan, is used for the prevention and treatment of a variety of thromboembolic disorders. Under dosing of warfarin may cause treatment failure and over dosing may cause bleeding because of its narrow therapeutic index. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Intentional Warfarin Sodium Overdose
- What is being tested?
- patient education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2012to Jul 2016
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >20 y/o
- Has been received warfarin therapy for 3 months and anticipated treatment duration of more than 3 months and a week
- Has legitimate indication for warfarin
- Has the capacity to understand the condition and implications of anticoagulant therapy
Who cannot join
- Who can't be regular follow-up at National Taiwan University Hospital.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 10051
Fe-Lin L WU, PhD, 886-2-23123456 ext. 88389, flwu@ntu.edu.tw
About this study
Warfarin, the major oral anticoagulant currently available in Taiwan, is used for the prevention and treatment of a variety of thromboembolic disorders. Under dosing of warfarin may cause treatment failure and over dosing may cause bleeding because of its narrow therapeutic index. Therefore, it is important to monitor prothrombin time (PT) and international normalize ratio (INR) periodically in order to evaluate the appropriateness of warfarin dosing.
Lots of factors influencing warfarin anticoagulation effects include polymorphisms of Cytochrome P450 2C9(CYP2C9)and Vitamin K epoxide reductase complex subunit 1(VKORC1)genes, age, weight, diet and concurrent medications. Taking into consideration of physicians' work load, pharmacist-managed anticoagulation clinics were set up to help strengthen patient care in US to ensure patient medication safety. In addition, differences in genetic polymorphisms between Chinese and Caucasian have great impacts on warfarin dosage, and there is still no consensus on warfarin utilization guideline in Taiwan. Pharmacist-managed anticoagulation clinics provide individualized care, consistent monitoring and patient education. Through this service, physicians can get the latest integrated information about their patients, patients themselves are more familiar with their medication, and adherence can be improved. Therefore, those who take warfarin will get better INR control, less adverse drug-related events and treatment failure.
This is the first prototype of pharmacist clinic for a specific medication in our hospital. The adverse drug events and coagulation function data collected through this program can be used for the implementation of warfarin treatment guideline in Taiwan in the future. The impact of pharmacist clinic can be evaluated by questionnaire of satisfaction and knowledge survey. It can be used as a model for implementing other pharmacist-managed clinics and improving patient medication safety.
- Conditions
- Intentional Warfarin Sodium Overdose
- Being tested
- patient education
- Keywords
- warfarin, pharmacist, anticoagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient educationOther
one by one patient education
| Study group | Role | What they receive |
|---|---|---|
| pharmacist care | Other | Not described Receives: Other: patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of INR in therapeutic range and incidence of complications
The INR value collected during the 3 months before enrollment and within 3 months after enrollment, which was proceeded by the one month wash-out period. The bleeding or thromboembolic events during this period were also collected. The outcome was assessed by the percentage of patient time with INR within the target range (1.8-2.4) and incidence of complications.
Measured: 3 months
Secondary outcomes (2)
patient's warfarin knowledge improvement
Patient's warfarin-related knowledge would be assessed by questionnaire. The validity of the questionnaire were assessed by experts. This questionnaire contained 9 aspects. the pre-test of warfarin-related knowledge questionnaire was conducted before patient education, and the post-test was conducted 2 months after enrollment in the pharmacist clinic. The correct percentage between pre-test and post-test would be compared.
Measured: 3 months
Patient's satisfaction to anticoagulation pharmacist clinic
Patient's satisfaction would be assessed by questionnaire. The validity of the questionnaire was assessed by experts. The per-test was conducted before the patient enrolled to pharmacist clinic, and the post-test was conducted 2 months after enrollment. The difference between pre-test and post-test would be evaluated.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startFeb 2012
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intentional Warfarin Sodium OverdoseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fe-Lin L WU, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972971
- Sponsor's protocol ID
- 201105109RC
- Status last verified
- Oct 2013
- First submitted
- 13 Oct 2013
- Last updated
- 31 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Establish a Novel Prototype of Clinical Pharmacy Services by Warfarin Consultation in a Pharmacist Clinic
- ClinicalTrials.gov ID
- NCT01972971
- Acronym / sponsor ID
- 201105109RC
- Conditions
- Intentional Warfarin Sodium Overdose
- Keywords
- warfarin, pharmacist, anticoagulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 31 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.
Warfarin, the major oral anticoagulant currently available in Taiwan, is used for the prevention and treatment of a variety of thromboembolic disorders. Under dosing of warfarin may cause treatment failure and over dosing may cause bleeding because of its narrow therapeutic index. Therefore, it is important to monitor prothrombin time (PT) and international normalize ratio (INR) periodically in order to evaluate the appropriateness of warfarin dosing.
Lots of factors influencing warfarin anticoagulation effects include polymorphisms of Cytochrome P450 2C9(CYP2C9)and Vitamin K epoxide reductase complex subunit 1(VKORC1)genes, age, weight, diet and concurrent medications. Taking into consideration of physicians' work load, pharmacist-managed anticoagulation clinics were set up to help strengthen patient care in US to ensure patient medication safety. In addition, differences in genetic polymorphisms between Chinese and Caucasian have great impacts on warfarin dosage, and there is still no consensus on warfarin utilization guideline in Taiwan. Pharmacist-managed anticoagulation clinics provide individualized care, consistent monitoring and patient education. Through this service, physicians can get the latest integrated information about their patients, patients themselves are more familiar with their medication, and adherence can be improved. Therefore, those who take warfarin will get better INR control, less adverse drug-related events and treatment failure.
This is the first prototype of pharmacist clinic for a specific medication in our hospital. The adverse drug events and coagulation function data collected through this program can be used for the implementation of warfarin treatment guideline in Taiwan in the future. The impact of pharmacist clinic can be evaluated by questionnaire of satisfaction and knowledge survey. It can be used as a model for implementing other pharmacist-managed clinics and improving patient medication safety.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pharmacist care | Other | Other: patient education |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >20 y/o
- Has been received warfarin therapy for 3 months and anticipated treatment duration of more than 3 months and a week
- Has legitimate indication for warfarin
- Has the capacity to understand the condition and implications of anticoagulant therapy
Key exclusion criteria (1 listed)
- Who can't be regular follow-up at National Taiwan University Hospital.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient educationone by one patient education | Other | pharmacist care |
Primary outcome
percentage of INR in therapeutic range and incidence of complications
Time frame: 3 months
The INR value collected during the 3 months before enrollment and within 3 months after enrollment, which was proceeded by the one month wash-out period. The bleeding or thromboembolic events during this period were also collected. The outcome was assessed by the percentage of patient time with INR within the target range (1.8-2.4) and incidence of complications.
2 secondary outcomes
patient's warfarin knowledge improvement
Time frame: 3 months
Patient's satisfaction to anticoagulation pharmacist clinic
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2013.
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.
Fe-Lin L WU, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patient education in people with Intentional Warfarin Sodium Overdose, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 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: status not confirmed, as of the sponsor's last update on 31 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fe-Lin L L WU, PHD (886-2-23123456 ext. 88389, flwu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of INR in therapeutic range and incidence of complications (time frame: 3 months). 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 31 Oct 2013.