TIPS or Anticoagulation in Portal Vein Thrombosis

An Investigator-initiated, Multicentre, Randomized, Trial Comparing Anticoagulation Alone Versus Transjugular Intrahepatic Portosystemic Shunt (TIPS) and Anticoagulation in Patients With Recent Obstructive Portal Vein Thrombosis

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03422419

Acronym

PROGRESS

Enrollment

Registered

2018-02-05

Start date

2018-08-01

Completion date

2021-07-31

Last updated

2018-11-01

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

Conditions

Thrombosis Portal Vein

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.

Interventions

DRUGHeparin

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

DEVICETIPS

transjugular intrahepatic portosystemic shunt deployment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

1. 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 2. Written informed consent

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 liver disease-

Design outcomes

Primary

Measure	Time frame
Proportion of patients with complete recanalization of the portal vein.	6 month

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026