Portal Vein ThrombosisLOCAPORTNCT05360641
Risk Factors for Recurrence of Thrombosis or Thrombotic Extension, in the Event of Acute Non-cirrhotic Portal Vein Thrombosis Secondary to a Local Cause.
An observational study of Portal Vein Thrombosis and Local Cause, run by University Hospital, Caen at 1 site in France.
Trial summary
In case of acute portal vein thrombosis (PVT) prothrombotic factors are identified in about 60% of cases, while a local condition is present in 30% of cases. Prothrombotic factors may indicate a long term anticoagulant therapy whereas the risk of recurrence seems low when a local condition is isolated (cholecystitis… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Portal Vein Thrombosis, Local Cause
- How many people
- 154 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2019to 31 Mar 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients 18 years of age or older with acute portal thrombosis segmental or truncal diagnosed in the context of a local cause inflammatory, infectious, trauma or abdominal surgery dating from less than 3 months.
Who may be able to join
- acute portal thrombosis segmental or truncal, diagnosed in the context of a local inflammatory, infectious, trauma or abdominal surgery cause, dating from less than 3 months.
- patients already included in european cohort ENVIE-VALDIG
Who cannot join
- liver cirrhosis
- liver, biliary or pancreatic neoplasia
- thrombosis limited to mesenteric vein, splenic vein or splenomesaraic confluence
- cavernoma or Budd-Chiari syndrom
Trial locations and contacts
1 site in 1 country.
About this study
In case of acute portal vein thrombosis (PVT) prothrombotic factors are identified in about 60% of cases, while a local condition is present in 30% of cases. Prothrombotic factors may indicate a long term anticoagulant therapy whereas the risk of recurrence seems low when a local condition is isolated (cholecystitis, angiocholitis, liver abces, diverticulitis, appendicitis, acute/chronic pancreatitis, chronic bowel inflammatory disease, acute hepatitis due to cytomegalovirus, bacteroïdes pylephlebitis, abdominal neoplasia such as adenocarcinoma of the colon, abdominal traumatism or surgery such as cholecystectomy, bariatric surgery or splenectomy). To date the impact of prothrombotic factors associated with local conditions responsible for acute PVT has not been well studied except for acute or chronic pancreatitis. No significant association has been pointed out in this pathology. The aim is to determine what are the risk factors of thrombotic recurrence or extension associated with local conditions responsible for acute non cirrhotic PVT, and to evaluate the rate of secondary long term anticoagulant therapy.
- Conditions
- Portal Vein Thrombosis, Local Cause
- Keywords
- liver vascular disease, portal vein thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of thrombosis at 5 years
Risk factor for recurrence of thrombosis at 5 years (regardless of territory), or splanchnic thrombotic extension, in case of acute non-cirrhotic PVT secondary to a local cause of infection, inflammation, trauma or abdominal surgery.
Measured: 5 years
Secondary outcomes (3)
Prevalence of thrombotic factors
Prevalence of thrombotic factors with its 95% confidence interval.
Measured: 5 years
Prothrombotic factors
Interest of a systematic search for prothrombotic factors in terms of prevention of recurrence of thrombosis, mortality (morbidity, mortality)
Measured: 5 years
Long-term anticoagulation
Percentage of indications for long-term anticoagulation at the end of the exhaustive search for prothrombotic factors: this percentage will be estimated with its IC 95
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start1 Aug 2019
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360641
- Sponsor's protocol ID
- LOCAPORT
- Acronym
- LOCAPORT
- Status last verified
- Apr 2022
- First submitted
- 12 Apr 2022
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Recurrence of Thrombosis or Thrombotic Extension, in the Event of Acute Non-cirrhotic Portal Vein Thrombosis Secondary to a Local Cause.
- ClinicalTrials.gov ID
- NCT05360641
- Acronym / sponsor ID
- LOCAPORT / LOCAPORT
- Conditions
- Portal Vein Thrombosis, Local Cause
- Keywords
- liver vascular disease, portal vein thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 4 May 2022 (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.
In case of acute portal vein thrombosis (PVT) prothrombotic factors are identified in about 60% of cases, while a local condition is present in 30% of cases. Prothrombotic factors may indicate a long term anticoagulant therapy whereas the risk of recurrence seems low when a local condition is isolated (cholecystitis, angiocholitis, liver abces, diverticulitis, appendicitis, acute/chronic pancreatitis, chronic bowel inflammatory disease, acute hepatitis due to cytomegalovirus, bacteroïdes pylephlebitis, abdominal neoplasia such as adenocarcinoma of the colon, abdominal traumatism or surgery such as cholecystectomy, bariatric surgery or splenectomy). To date the impact of prothrombotic factors associated with local conditions responsible for acute PVT has not been well studied except for acute or chronic pancreatitis. No significant association has been pointed out in this pathology. The aim is to determine what are the risk factors of thrombotic recurrence or extension associated with local conditions responsible for acute non cirrhotic PVT, and to evaluate the rate of secondary long term anticoagulant therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients 18 years of age or older with acute portal thrombosis segmental or truncal diagnosed in the context of a local cause inflammatory, infectious, trauma or abdominal surgery dating from less than 3 months.
Key inclusion criteria (2 listed)
- acute portal thrombosis segmental or truncal, diagnosed in the context of a local inflammatory, infectious, trauma or abdominal surgery cause, dating from less than 3 months.
- patients already included in european cohort ENVIE-VALDIG
Key exclusion criteria (4 listed)
- liver cirrhosis
- liver, biliary or pancreatic neoplasia
- thrombosis limited to mesenteric vein, splenic vein or splenomesaraic confluence
- cavernoma or Budd-Chiari syndrom
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrence of thrombosis at 5 years
Time frame: 5 years
Risk factor for recurrence of thrombosis at 5 years (regardless of territory), or splanchnic thrombotic extension, in case of acute non-cirrhotic PVT secondary to a local cause of infection, inflammation, trauma or abdominal surgery.
3 secondary outcomes
Prevalence of thrombotic factors
Time frame: 5 years
Prothrombotic factors
Time frame: 5 years
Long-term anticoagulation
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Portal Vein Thrombosis and Local Cause, run by University Hospital, Caen at 1 site in France.
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 4 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: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recurrence of thrombosis at 5 years (time frame: 5 years). 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 26 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.