Incidence of Venous Thromboembolic Disease and Portal Vein Thrombosis After Hepatectomy. A Cohort Study.

Hospital Italiano de Buenos Aires

Status: Unknown

Conditions: Portal Thrombosis; Pulmonary Embolism; Venous Thrombosis

Study type: Observational

Funder types: Other

Identifiers

NCT02597218

2611

Details and patient eligibility

About

Observational. Retrospective cohort.

Full description

Venous thromboembolism (VTE) is a disease that includes both deep vein thrombosis (DVT) and pulmonary embolism (PE). It is a common, potentially lethal disorder that can occur among postoperative patients. Liver surgery implies a prothrombotic state, as a result of an alteration of the equilibrium between synthesis and use of pro and anti coagulant factors after a parenquimal resection. The use of antithrombotic prophylaxis following surgery is not standarized, and current practices vary depending on the attendant surgeon's particular experience or hospital's customs and habits.

In published research, postoperative patients have been studied as a whole so far. There is little evidence regarding patients undergoing hepatectomy. Furthermore, the use and need of extended prophylaxis remains unexplored in this group of patients.

The objetives of the following study are:

• To estimate the incidence of symptomatic venous thromboembolism (VTE) [deep vein thrombosis (DVT), pulmonary embolism (PE) and fatal PE] in a third level center in patients undergoing any hepatectomy within 90 days after surgery.
• To estimate the incidence of portal thrombosis (PT) in a third level center in patients undergoing any hepatectomy within 90 days after surgery.
• To identify and describe factors associated to the development of VTE in patients following hepatectomy.
• To identify and describe factors associated to the development of PT in patients following hepatectomy.
• To describe major bleedings or minor but clinically relevant bleedings during the period in which those patients received chemical thromboprophylaxis.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Older than 18 years old.
• Following hepatic surgery.

Exclusion criteria

• Living donor
• Venous thromboembolism within 6 months previous to surgery.

Trial design

350 participants in 1 patient group

Patients following hepatectomy

Description:

Patients following hepatectomy of any type, any gender. Roughly, we will describe: type of resection, presence of cancer,use of mechanical/pharmacological prophylaxis, major/minor bleedings ocurring during observation period. Outcomes: Venous thromboembolism (VTE)\[deep vein thrombosis (DVT) and pulmonary embolism (PE)\] and portal thrombosis (PT).