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

• Conditions: Pulmonary Embolism; Venous Thrombosis; Portal Thrombosis

• Registration Number: NCT02597218
• Lead Sponsor: Hospital Italiano de Buenos Aires

Brief Summary

Observational. Retrospective cohort.

Detailed 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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-11-03
• Study First Submitted QC: 2015-11-03
• Study First Posted: 2015-11-05
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-09
• Last Update Posted: 2019-08-13
• Primary Completion: 2019-10
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Venous thromboembolism (VTE)	90 days following surgery	Includes deep vein thrombosis (DVT) and pulmonary embolism (PE)

Secondary Outcome Measures

Name	Time	Method
Minor bleeding	90 days following surgery	Any bleeding that doesn't fulfill "major bleeding" criteria.
Major bleeding	90 days following surgery	Any bleeding causing: death, serious threat to life, requirement of active medical intervention, 2 or more red blood cell units transfusion, localized in retroperitoneum, intracraneal or intraocular
Portal Thrombosis (PT)	90 days following surgery	Portal thrombosis

Trial Locations

Locations (1)

Hospital Italiano de Buenos Aires; 🇦🇷 Capital Federal, Buenos Aires, Argentina