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
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||40 patients received rivaroxaban|
|Masking:||None (Open Label)|
|Masking Description:||open label|
|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|
Active Comparator: study group
acute non-neoplastic PVT, compensated cirrhosis, acute PVT onset within 1 week after initial diagnosis
- treated with 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
- complete recanalization of the portal vein [ Time Frame: 6 months ]bedside ultrasonography for detection of thrombus resolution
- major bleeding [ Time Frame: 6 months ]Questionnaire about symptoms of bleeding (hematemesis, melena, epistaxis, gum bleeding, vaginal bleeding, subcutaneous bleeding)
- Hepatotoxicity [ Time Frame: 6 MONTHS ]liver function tests as AST, ALT (IU/L), total bilirubin (mg/dl)
- short term survival [ Time Frame: 1 year ]impact of treating portal vein thrombosis on short term survival