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OpenTrials
Completed

NCT Number: NCT05360641

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu de Caen

Caen, Calvados, 14033, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Prevalence of thrombotic factors

    Time frame: 5 years

    Prevalence of thrombotic factors with its 95% confidence interval.

  2. Prothrombotic factors

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Acronym: LOCAPORT

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 4, 2022
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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