Thrombosis Portal VeinPhase 3PROGRESSNCT03422419
TIPS or Anticoagulation in Portal Vein Thrombosis
A Phase 3 study testing Heparin and TIPS in people with Thrombosis Portal Vein, run by Insel Gruppe AG, University Hospital Bern.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thrombosis Portal Vein
- What is being tested?
- Heparin and TIPS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2018to 31 Jul 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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-
About this study
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
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
- Being tested
- Heparin, TIPS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeparinDrug
The choice of the anticoagulant medication in terms of duration and dose will be determined by the treating physician.
TIPSDevice
transjugular intrahepatic portosystemic shunt deployment
| Study group | Role | What they receive |
|---|---|---|
| TIPS+Anticoagulation | Experimental | Not described Receives: Drug: Heparin; Device: TIPS |
| Anticoagulation | Active comparator | Not described Receives: Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with complete recanalization of the portal vein".
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start1 Aug 2018 (estimated)
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Jul 2021 (estimated)
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombosis Portal VeinStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea De Gottardi, Prof. Dr. med, Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422419
- Sponsor's protocol ID
- IICT2017_PROGRESS
- Acronym
- PROGRESS
- Status last verified
- Oct 2018
- First submitted
- 30 Jan 2018
- Last updated
- 1 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03422419
- Acronym / sponsor ID
- PROGRESS / IICT2017_PROGRESS
- Conditions
- Thrombosis Portal Vein
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Aug 2018 (estimated)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIPS+Anticoagulation | Experimental | Drug: Heparin, Device: TIPS |
| Anticoagulation | Active comparator | Drug: Heparin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- Malignant Portal Vein thrombosis (neoplastic invasion)
- Intraabdominal malignancy
- Chronic diseases limiting life expectancy in the short term (6 months)
- Liver transplantation
- Unwillingness to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeparinThe choice of the anticoagulant medication in terms of duration and dose will be determined by the treating physician. | Drug | Anticoagulation, TIPS+Anticoagulation |
| TIPStransjugular intrahepatic portosystemic shunt deployment | Device | TIPS+Anticoagulation |
Primary outcome
Proportion of patients with complete recanalization of the portal vein".
Time frame: 6 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea De Gottardi, Prof. Dr. med principal investigator
Insel Gruppe AG, University Hospital Bern
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Heparin and TIPS in people with Thrombosis Portal Vein, run by Insel Gruppe AG, University Hospital Bern.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with complete recanalization of the portal vein". (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2018.