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

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ClinicalTrials.gov Identifier: NCT03201367
Recruitment Status : Completed
First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
Amr Shaaban Hanafy, Zagazig University

Brief 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.

Condition or disease Intervention/treatment Phase
Portal Vein Thrombosis Drug: Rivaroxaban Other: symptomatic therapy for ascites, abdominal pain Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 40 patients received rivaroxaban
Masking: None (Open Label)
Masking Description: open label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Rivaroxaban in the Management of Acute Non-neoplastic Portal Vein Thrombosis in HCV Related Compensated Cirrhosis
Actual Study Start Date : May 1, 2014
Actual Primary Completion Date : August 1, 2016
Actual Study Completion Date : August 1, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Arm Intervention/treatment
Active Comparator: study group

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

- treated with rivaroxaban

Drug: Rivaroxaban
Rivaroxaban 10 mg/12 hour

Placebo Comparator: control group
acute non-neoplastic PVT, compensated cirrhosis, acute PVT onset within 1 week after initial diagnosis receive placebo
Other: symptomatic therapy for ascites, abdominal pain



Primary Outcome Measures :
  1. complete recanalization of the portal vein [ Time Frame: 6 months ]
    bedside ultrasonography for detection of thrombus resolution


Secondary Outcome Measures :
  1. major bleeding [ Time Frame: 6 months ]
    Questionnaire about symptoms of bleeding (hematemesis, melena, epistaxis, gum bleeding, vaginal bleeding, subcutaneous bleeding)

  2. Hepatotoxicity [ Time Frame: 6 MONTHS ]
    liver function tests as AST, ALT (IU/L), total bilirubin (mg/dl)


Other Outcome Measures:
  1. short term survival [ Time Frame: 1 year ]
    impact of treating portal vein thrombosis on short term survival



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amr Shaaban Hanafy, Assistant professor, Zagazig University
ClinicalTrials.gov Identifier: NCT03201367     History of Changes
Other Study ID Numbers: 3779
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amr Shaaban Hanafy, Zagazig University:
Portal vein
thrombosis
acute
rivaroxaban

Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants