Thrombosis Portal Vein Clinical Trial
— PROGRESSOfficial 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
| Verified date | October 2018 |
| Source | University Hospital Inselspital, Berne |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | July 31, 2021 |
| Est. primary completion date | October 31, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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- |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Inselspital, Berne |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of patients with complete recanalization of the portal vein". | 6 month |