Back to resultsTIPS or Anticoagulation in Portal Vein Thrombosis (PROGRESS)
Primary Purpose
Thrombosis Portal Vein
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Heparin
TIPS
Sponsored by
About this trial
This is an interventional treatment trial for Thrombosis Portal Vein
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TIPS+Anticoagulation
Anticoagulation
Arm Description
Outcomes
Primary Outcome Measures
Proportion of patients with complete recanalization of the portal vein".
Secondary Outcome Measures
Full Information
NCT ID
NCT03422419
First Posted
January 30, 2018
Last Updated
October 30, 2018
Sponsor
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT03422419
Brief Title
TIPS or Anticoagulation in Portal Vein Thrombosis
Acronym
PROGRESS
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Why Stopped
lack of funding
Study Start Date
August 1, 2018 (Anticipated)
Primary Completion Date
October 31, 2020 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis Portal Vein
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TIPS+Anticoagulation
Arm Type
Experimental
Arm Title
Anticoagulation
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Heparin
Intervention Description
The choice of the anticoagulant medication in terms of duration and dose will be determined by the treating physician.
Intervention Type
Device
Intervention Name(s)
TIPS
Intervention Description
transjugular intrahepatic portosystemic shunt deployment
Primary Outcome Measure Information:
Title
Proportion of patients with complete recanalization of the portal vein".
Time Frame
6 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea De Gottardi, Prof. Dr. med
Organizational Affiliation
Insel Gruppe AG, University Hospital Bern
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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TIPS or Anticoagulation in Portal Vein Thrombosis
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