LOCAPORT: Risk Factors for Recurrence of Thrombosis or Thrombotic Extension, in the Event of Acute Non-cirrhotic Portal Vein Thrombosis Secondary to a Local Cause.

Sponsor
University Hospital, Caen (Other)
Overall Status
Completed
CT.gov ID
NCT05360641
Collaborator
(none)
154
1
32
4.8

Study Details

Study Description

Brief 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, 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    154 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    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.
    Actual Study Start Date :
    Aug 1, 2019
    Actual Primary Completion Date :
    Mar 31, 2022
    Actual Study Completion Date :
    Mar 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Recurrence of thrombosis at 5 years [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.

    Secondary Outcome Measures

    1. Prevalence of thrombotic factors [5 years]

      Prevalence of thrombotic factors with its 95% confidence interval.

    2. Prothrombotic factors [5 years]

      Interest of a systematic search for prothrombotic factors in terms of prevention of recurrence of thrombosis, mortality (morbidity, mortality)

    3. Long-term anticoagulation [5 years]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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

    Exclusion Criteria:
    • liver cirrhosis

    • liver, biliary or pancreatic neoplasia

    • thrombosis limited to mesenteric vein, splenic vein or splenomesaraic confluence

    • cavernoma or Budd-Chiari syndrom

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chu de Caen Caen Calvados France 14033

    Sponsors and Collaborators

    • University Hospital, Caen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Isabelle OLLIVIER, Principal Investigator, University Hospital, Caen
    ClinicalTrials.gov Identifier:
    NCT05360641
    Other Study ID Numbers:
    • LOCAPORT
    First Posted:
    May 4, 2022
    Last Update Posted:
    May 4, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Isabelle OLLIVIER, Principal Investigator, University Hospital, Caen
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 4, 2022