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

NCT05360641 | Completed

• 1 other identifier: LOCAPORT
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Portal Vein Thrombosis; Local Cause

Keywords

liver vascular disease; portal vein thrombosis

Outcome Measures

Primary Outcomes (1)

• 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.

  5 years

Secondary Outcomes (3)

• Prevalence of thrombotic factors

  5 years

• Prothrombotic factors

  5 years

• Long-term anticoagulation

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• liver cirrhosis
• liver, biliary or pancreatic neoplasia
• thrombosis limited to mesenteric vein, splenic vein or splenomesaraic confluence
• cavernoma or Budd-Chiari syndrom

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Chu de Caen

Caen, Calvados, 14033, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: May 4, 2022
• Study Start: August 1, 2019
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: March 26, 2025

Record last verified: 2022-04

Locations

FR (1)