TIPS or Anticoagulation in Portal Vein Thrombosis

NCT03422419 | Withdrawn Phase 3

• 1 other identifier: IICT2017_PROGRESS
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Thrombosis Portal Vein

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with complete recanalization of the portal vein".

  6 month

Study Arms (2)

TIPS+Anticoagulation

EXPERIMENTAL

Drug: Heparin; Device: TIPS

Anticoagulation

ACTIVE COMPARATOR

Drug: Heparin

Interventions

Heparin DRUG

The choice of the anticoagulant medication in terms of duration and dose will be determined by the treating physician.

Anticoagulation; TIPS+Anticoagulation

TIPS DEVICE

transjugular intrahepatic portosystemic shunt deployment

TIPS+Anticoagulation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Recent complete thrombosis of the extrahepatic portal vein either with or without the involvement of intrahepatic branches and with or without involvement of splenic vein and superior mesenteric vein
• Written informed consent

You may not qualify if:

• Malignant Portal Vein thrombosis (neoplastic invasion)
• Intraabdominal malignancy
• Chronic diseases limiting life expectancy in the short term (6 months)
• Liver transplantation
• Unwillingness to participate
• Contraindications to TIPS (including past or present hepatic encephalopathy Grade ≥2)
• Child-Pugh-Turcotte score 11 or more points in patients with advanced chronic liver disease-

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

MeSH Terms

Interventions

Heparin; Portasystemic Shunt, Transjugular Intrahepatic

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Portasystemic Shunt, Surgical; Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures

Study Officials

• Andrea De Gottardi, Prof. Dr. med

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 5, 2018
• Study Start: August 1, 2018
• Primary Completion: October 31, 2020
• Study Completion: July 31, 2021
• Last Updated: November 1, 2018

Record last verified: 2018-10