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

Portal Vein Thrombosis Clinical Trial

— LOCAPORT  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05360641
• Other study ID #: LOCAPORT
• Status: Completed
• Start date: August 1, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: April 2022
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Portal Vein Thrombosis
• Recurrence
• Thrombosis
• Venous Thrombosis

Locations

Country	Name	City	State
France	Chu de Caen	Caen	Calvados

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prevalence of thrombotic factors	Prevalence of thrombotic factors with its 95% confidence interval.	5 years
Secondary	Prothrombotic factors	Interest of a systematic search for prothrombotic factors in terms of prevention of recurrence of thrombosis, mortality (morbidity, mortality)	5 years
Secondary	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	5 years