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

Efficacy and Safety of Rivaroxaban in the Management of Acute Non-neoplastic Portal Vein Thrombosis in HCV Related Compensated Cirrhosis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03201367
Enrollment
40
Registered
2017-06-28
Start date
2014-05-01
Completion date
2016-08-01
Last updated
2017-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Portal Vein Thrombosis

Keywords

Portal vein, thrombosis, acute, rivaroxaban

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.

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.

Interventions

DRUGRivaroxaban

Rivaroxaban 10 mg/12 hour

OTHERsymptomatic therapy for ascites, abdominal pain

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

open label

Intervention model description

40 patients received rivaroxaban

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
complete recanalization of the portal vein6 monthsbedside ultrasonography for detection of thrombus resolution

Secondary

MeasureTime frameDescription
major bleeding6 monthsQuestionnaire about symptoms of bleeding (hematemesis, melena, epistaxis, gum bleeding, vaginal bleeding, subcutaneous bleeding)
Hepatotoxicity6 MONTHSliver function tests as AST, ALT (IU/L), total bilirubin (mg/dl)

Other

MeasureTime frameDescription
short term survival1 yearimpact of treating portal vein thrombosis on short term survival

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026