Efficacy and Safety of Rivaroxaban in Acute Non-neoplastic Portal Vein Thrombosis in HCV

Zagazig University

Status: Completed

Conditions: Portal Vein Thrombosis

Treatments: Drug: Rivaroxaban; Other: symptomatic therapy for ascites, abdominal pain

Study type: Interventional

Funder types: Other

Identifiers

NCT03201367

3779

Details and patient eligibility

About

Portal vein thrombosis (PVT) in patients with liver cirrhosis may be due to neoplastic growth or non-neoplastic causes.

• Treating PVT with anticoagulation in liver cirrhosis is difficult to be established but may be of great benefit in acute symptomatic PVT.
• The ultimate goal is complete recanalization of the portal vein without inducing major bleeding, abnormal liver function tests or increased mortality.

Full description

Out of 220 patients with chronic HCV who had undergone splenectomy due to hypersplenism in the period extending from May 2014 until August 2016; 36 participants (16.4%) were selected. They were presented with acute PVT. Also, the investigators enrolled 4 patients who were presented with PVT due to portal pyemia complicated infected thrombosed internal piles (n=1), appendicular abscess (n=1), ulcerative colitis (n=2).

Control group It included 30 patients who had acute non-neoplastic PVT with the same inclusion criteria and were given symptomatic therapy for ascites, abdominal pain and followed synchronously with the study group.

Laboratory investigations They included investigation preliminary to splenectomy as liver function tests, coagulation profile, renal function tests, complete blood count, reticulocyte count and bone marrow aspiration. For each patient, Child-Pugh (CTP) and MELD scores were calculated.

Abdominal Ultrasonography (USG) Cirrhotic echo pattern, criteria of portal hypertension, ascites, HCC were excluded Color Doppler Sonography to confirm the diagnosis of PVT. Upper GI Endoscopy All the patients before splenectomy were exposed to upper GI endoscopy to detect the presence and grading of gastro-esophageal varices.

Protocol of therapy Enoxaparin was initiated at a dose of 1mg/kg every 12 hours subcutaneously for 3 days then treatment was continued with rivaroxaban 10mg/12 hr. Rivaroxaban was started 2 hours before the next dose of enoxaparin.

• Follow up every week with a questionnaire about symptoms of bleeding (hematemesis, melena, epistaxis, gum bleeding, vaginal bleeding, subcutaneous bleeding), worsening or improvement of abdominal pain.
• Bedside ultrasonography for detection of thrombus resolution and presence or improvement of ascites every 2 weeks Laboratory follow-up which included serum creatinine, complete blood count, and liver function tests to detect if there any side effects of the therapy every 2 weeks.

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute non-neoplastic portal vein thrombosis
• Compensated cirrhosis (Child class A-B)
• The onset of PVT is within 1 week.

Exclusion criteria

• Decompensated liver disease
• Bleeding tendency or recent bleeding event as bleeding peptic ulcer or oesophageal varices
• Neoplastic invasion of the portal vein
• Renal impairment with the creatinine clearance ≤ 30 ml/min
• Pregnancy and breastfeeding
• Hypersensitivity to rivaroxaban
• Concomitant treatment with another anticoagulant
• Concomitant use of clopidogrel.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

study group

Active Comparator group

Description:

acute non-neoplastic PVT, compensated cirrhosis, acute PVT onset within 1 week after initial diagnosis - treated with rivaroxaban

Treatment:

Drug: Rivaroxaban

control group

Placebo Comparator group

Description:

acute non-neoplastic PVT, compensated cirrhosis, acute PVT onset within 1 week after initial diagnosis receive placebo

Treatment:

Other: symptomatic therapy for ascites, abdominal pain