Portal vein edoxaban study

JRCT ID: jRCTs041190015

Registered date:10/04/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Portal vein thrombus
• Date of first enrollment: 17/01/2018
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Administration of edoxaban to portal vein thrombosis.

Outcome(s)

• Primary Outcome: Portal vein thrombus reduction rate
• Secondary Outcome: Incidence of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 79age old
• Gender: Both

Include criteria

Clinically (histologically or image) has been diagnosed as chronic liver disease.
Patient who has been confirmed to have thrombus on the image, portal vein, superior mesenteric vein or / and splenic vein.
The age (full age) at the time of registration is 20 years old and under 80 years old.
The latest inspection value within 14 days before registration (same day as two weeks before the registration day is acceptable) satisfies all of the following.
Hemoglobin 9.0 g / dl or more (male) , 8.0 g / dl or more (female) .
Platelet count 50,000 / mm 3 or more.
Creatinine clearance 30 ml / min or more.
Child-Pugh classification A or B.
Weight 40 kg or more.
The patient consent has been obtained from the patient concerning the participation in the document.

Exclude criteria

Child-Pugh classification C.
Endoscopic examination confirmed the presence of lesions at risk of gastrointestinal bleeding (esophageal gastric varices, stomach / duodenal ulcer, gastric antral vascular dilation, etc.), and no preventive measures were taken.
It has an active malignancy.
Patient taking anticoagulant or / and antiplatelet drugs.
Patients with a history of clear bleeding symptoms such as cerebral haemorrhage.
Patient who weighs less than 40 kg at registration.
A woman who is pregnant or has a possibility of pregnancy, within 28 days after childbirth, or who is breastfeeding. A man who wishes to become a partner's pregnant.
Mental disease or psychiatric symptoms are merged and it is judged that participation in the examination is difficult.
It has severe hypersensitivity to the ingredients of Edoxaban.
Due to drug allergy, neither CT nor MRI using a contrast agent can be performed.
Other patients who judge that the doctor in charge is inappropriate to participate in this study.

Related Information

• Primary Sponsor: Kaneko Shuichi
• Secondary ID(s): UMIN000030108