This was a prospective, open-label, pilot interventional clinical study conducted on Egyptian patients with liver cirrhosis complicated by portal vein thrombosis (PVT) who were indicated for anticoagulation therapy. The study aimed to evaluate the clinical applicability of Simcyp®-guided warfarin initiation doses according to Child-Pugh class, focusing on the time required to achieve a therapeutic INR and the safety of anticoagulation during the initiation phase.
This was a prospective, open-label, pilot interventional clinical study conducted on adult cirrhotic patients with radiologically confirmed portal vein thrombosis. A total of twenty-one patients were enrolled from the outpatient clinics of the Hepatology, Gastroenterology, and Infectious Diseases Department at Kafrelsheikh University Hospital between March 2024 and March 2025. Before initiation of anticoagulation therapy, all participants underwent comprehensive baseline clinical and laboratory assessments, including detailed medical history with emphasis on bleeding and thrombotic risk, physical examination, complete blood count, liver and renal function tests, and baseline coagulation profile. Eligible patients were classified according to Child-Pugh score into class A or B. Patients with Child-Pugh class A (n = 10) received warfarin 3 mg once daily, while patients with Child-Pugh class B (n = 11) received warfarin 2 mg once daily. Initial dosing was guided by Simcyp® model predictions and the closest commercially available strengths. Enoxaparin was administered as bridging therapy at a therapeutic dose of 1 mg/kg twice daily until achievement of the target INR. During the warfarin initiation phase, daily INR monitoring was performed, and dose adjustments were carried out using standardized clinical titration principles until a stable therapeutic INR (2.0-3.0) was achieved on two consecutive measurements. Patients were closely monitored throughout the follow-up period for treatment-related adverse events, with particular emphasis on bleeding complications. Bleeding events were systematically assessed and classified as minor or major, in addition to monitoring for any thromboembolic events.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Warfarin is a vitamin K antagonist approved for the treatment of thromboembolic disorders and was used in this study for anticoagulation in cirrhotic patients with portal vein thrombosis.
Warfarin is a vitamin K antagonist approved for the treatment of thromboembolic disorders and was used in this study for anticoagulation in cirrhotic patients with portal vein thrombosis.
Kafrelsheikh University
Cairo, Egypt
Time to Achieve Therapeutic INR
The number of days from initiation of warfarin therapy until an INR value within the therapeutic range (≥ 2.0) was documented.
Time frame: From initiation of warfarin therapy until achievement of therapeutic INR (up to 14 days)
Average Warfarin Dose During Initiation Phase
The mean daily warfarin dose required to achieve therapeutic anticoagulation during the initiation phase.
Time frame: From initiation of warfarin therapy until achievement of therapeutic INR (up to 14 days)
Proportion of Patients Achieving Therapeutic INR Within 3-5 Days
The percentage of patients who achieved therapeutic INR (≥ 2.0) within 3 to 5 days after initiation of warfarin therapy.
Time frame: Within 3-5 days after warfarin initiation
Follow-up Duration During Warfarin Initiation Phase
The duration of patient follow-up during the warfarin initiation phase, measured in days.
Time frame: From initiation of warfarin therapy until achievement of therapeutic INR (up to 14 days)
Incidence of Over-Anticoagulation
The occurrence of excessive anticoagulation, defined as an international normalized ratio (INR) value greater than 4 during the initiation phase.
Time frame: From initiation of warfarin therapy until achievement of therapeutic INR (up to 14 days)
Incidence of Bleeding Events
The occurrence of bleeding complications during the study follow-up period, classified as minor or major according to standard clinical criteria.
Time frame: From initiation of warfarin therapy until achievement of therapeutic INR (up to 14 days)
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Masking
NONE
Enrollment
21
Incidence of Thromboembolic Events
The occurrence of any new thromboembolic events during the follow-up period after initiation of warfarin therapy.
Time frame: From initiation of warfarin therapy until achievement of therapeutic INR (up to 14 days)