TIPS or Anticoagulation in Portal Vein Thrombosis

Last updated: October 30, 2018
Sponsor: University Hospital Inselspital, Berne
Overall Status: Trial Not Available

Phase

3

Condition

Venous Thrombosis

Claudication

Venous Thromboembolism

Treatment

N/A

Clinical Study ID

NCT03422419
IICT2017_PROGRESS
  • All Genders

Study Summary

The PROGRESS is an investigator-initiated, multicentre, randomized, trial comparing anticoagulation, which is the currently most frequently used treatment, alone, versus transjugular intrahepatic portosystemic shunt (TIPS) combined with anticoagulation, in patients presenting with recent obstructive portal vein thrombosis (ROPVT). The rationale of this study is to significantly increase the proportion of patients that achieve a complete or partial recanalization of the portal vein. The intervention of this study consists in TIPS deployment and catheter based clot removal in addition to anticoagulation. The investigators retain that this intervention will increase the proportion of patients with an open portal vein from 38% with anticoagulation alone to 83% with anticoagulation and TIPS after 6 months. Both anticoagulant therapy and clot removal/TIPS are treatments that are currently available and accepted indications for the treatment of ROPVT. Anticoagulation will be performed with unfractioned heparin or low molecular weight heparin initially and with vitamin K antagonists in the long term. The investigators plan to collect blood for biobanking at the time of inclusion and after 6 months. Blood samples for a biobank will be collected.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Recent complete thrombosis of the extrahepatic portal vein either with or without theinvolvement of intrahepatic branches and with or without involvement of splenic veinand superior mesenteric vein

  2. Written informed consent

Exclusion

Exclusion Criteria:

  1. Malignant Portal Vein thrombosis (neoplastic invasion)

  2. Intraabdominal malignancy

  3. Chronic diseases limiting life expectancy in the short term (6 months)

  4. Liver transplantation

  5. Unwillingness to participate

  6. Contraindications to TIPS (including past or present hepatic encephalopathy Grade ≥2)

  7. Child-Pugh-Turcotte score 11 or more points in patients with advanced chronic liverdisease-

Study Design

Study Start date:
August 01, 2018
Estimated Completion Date:
July 31, 2021

Connect with a study center

  • Inselspital

    Bern, BE 3010
    Switzerland

    Site Not Available

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