Efficacy and Safety of Rivaroxaban in Acute Non-neoplastic Portal Vein Thrombosis in HCV
Condition: Portal Vein Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Interventional

Summary: 
      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.
    

Detailed 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.
    

Intervention name(s): Rivaroxaban; symptomatic therapy for ascites, abdominal pain
Intervention type(s): Drug; Other
Intervention description(s): Rivaroxaban 10 mg/12 hour
Intervention MeSH terms: Rivaroxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 40 patients received rivaroxaban
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Portal vein; thrombosis; acute; rivaroxaban