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

Sponsoren

Hauptsponsor: Zagazig University

Quelle Zagazig University
Kurze Zusammenfassung

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.

detaillierte Beschreibung

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.

Gesamtstatus Completed
Anfangsdatum May 1, 2014
Fertigstellungstermin August 1, 2016
Primäres Abschlussdatum August 1, 2016
Phase N/A
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
complete recanalization of the portal vein 6 months
Sekundäres Ergebnis
Messen Zeitfenster
major bleeding 6 months
Hepatotoxicity 6 MONTHS
Einschreibung 40
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: Rivaroxaban

Beschreibung: Rivaroxaban 10 mg/12 hour

Armgruppenetikett: study group

Interventionsart: Other

Interventionsname: symptomatic therapy for ascites, abdominal pain

Armgruppenetikett: control group

Teilnahmeberechtigung

Kriterien:

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.

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: 70 Years

Gesunde Freiwillige: No

Überprüfungsdatum

June 2017

Verantwortliche Partei

Art: Principal Investigator

Ermittlerzugehörigkeit: Zagazig University

Vollständiger Name des Ermittlers: Amr Shaaban Hanafy

Ermittlertitel: Assistant professor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 2
Armgruppe

Etikette: study group

Art: Active Comparator

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

Etikette: control group

Art: Placebo Comparator

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

Patientendaten Undecided
Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Beschreibung des Interventionsmodells: 40 patients received rivaroxaban

Hauptzweck: Treatment

Maskierung: None (Open Label)

Maskierungsbeschreibung: open label

Quelle: ClinicalTrials.gov