Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2018-12-31
2019-12-31
Brief Summary
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The study will show the prevalence of sub optimal anti coagulation among patients with prosthetic cardiac valves that will undergo warfarin therapy.
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Detailed Description
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Warfarin as a vitamin k antagonist is widely used to decrease risk of thromboembolism but need strict monitoring for INR to avoid warfarin failure or hemorrhage.
It acts through inhibiting an enzyme called the vitamin K1 2,3 epoxide reductase complex, subunit1 (VKORC1).
All patients with mechanical heart valves need the oral anticoagulation to keep the INR between 2.5:3.5 according to valve type, position and other comorbid conditions.
However some patients need higher than expected doses of warfarin to get their (INR) into the target therapeutic range.
Resistance to warfarin has been described as the inability to prolong the prothrombin time or raise the international normalized ratio (INR) into the therapeutic range when the drug is given at normally prescribed doses.
Resistance is different than warfarin failure ,which is defined as a new thrombotic event despite a therapeutic prothrombin time and INR .
The causes of warfarin resistance can be either acquired from high consumption of vitamin K or C ,decreased absorption or increased clearance of the drug ,dietary or drug interactions or hereditary by genetic factors that result either in faster metabolism of the drug (a form of pharmacokinetic resistance) or in lower activity of the drug (pharmacodynamic resistance).
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Patients with chronic liver or kidney diseases
Patients with chronic liver diseases may affect warfarin therapeutic outcome as liver is the site of metabolism of the drug by cytochrome p 450 enzymes so it decrease warfarin absorption
Kidney diseases also affect the clearance of the drug these patients will undergo liver function tests and kidney function tests
Liver and kidney function tests for patients with chronic liver or kidney diseases
Tests will be done to patients with history suggestive of chronic liver or renal diseases or for patients clinically suspected
Non compliance of the patient
Missed dose of the warfarin or intermittent drug intake may affect drug therapeutic outcome as well as changing time of drug administration during the day
Non compliance of the patient
I will order all my patients to take the drug at 10 am and assure the daily in taking of the dose and they will be followed up
Drugs or food interactions
Administration of other drugs beside warfarin may affect its therapeutic outcome either by inhibition or synergism certain food may also interfere with warfarin especially vitamin k and c rich food so patients will be followed up for drug or food interactions
Drug or food interactions
The patient will be in contact with the researcher for any drug added with warfarin in case of other co morbidity conditions and follow up his/her CBC and INR for measuring its effect on warfarin finding out the effect of food on warfarin therapeutic outcome
Interventions
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Liver and kidney function tests for patients with chronic liver or kidney diseases
Tests will be done to patients with history suggestive of chronic liver or renal diseases or for patients clinically suspected
Non compliance of the patient
I will order all my patients to take the drug at 10 am and assure the daily in taking of the dose and they will be followed up
Drug or food interactions
The patient will be in contact with the researcher for any drug added with warfarin in case of other co morbidity conditions and follow up his/her CBC and INR for measuring its effect on warfarin finding out the effect of food on warfarin therapeutic outcome
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with target INR (2.5-3.5)
* Patients with hypoalbumenimia and chronic liver diseases
ALL
Yes
Sponsors
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Assiut University
OTHER
Responsible Party
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Mariam Sobhy Gerges
Resident hematologist at internal medicine department
Central Contacts
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Ahmed Ali Obiedallah an assistant professor at internal medicine department, MD
Role: CONTACT
Related Links
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Management of Supratherapeutic International Normalized Ratio without Bleeding after Warfarin Use
Other Identifiers
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Sub optimal anti coagulation
Identifier Type: -
Identifier Source: org_study_id
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