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TIPS or Anticoagulation in Portal Vein Thrombosis (PROGRESS)

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ClinicalTrials.gov Identifier: NCT03422419
Recruitment Status : Withdrawn (lack of funding)
First Posted : February 5, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Study Description
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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.

Condition or disease Intervention/treatment Phase
Thrombosis Portal Vein Drug: Heparin Device: TIPS Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Heparin

Arms and Interventions
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Arm Intervention/treatment
Experimental: TIPS+Anticoagulation Drug: Heparin
The choice of the anticoagulant medication in terms of duration and dose will be determined by the treating physician.

Device: TIPS
transjugular intrahepatic portosystemic shunt deployment
Active Comparator: Anticoagulation Drug: Heparin
The choice of the anticoagulant medication in terms of duration and dose will be determined by the treating physician.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients with complete recanalization of the portal vein". [ Time Frame: 6 month ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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-
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03422419


Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Andrea De Gottardi, Prof. Dr. med University Hospital Inselspital, Berne
More Information
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03422419    
Other Study ID Numbers: IICT2017_PROGRESS
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
 Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action