Clinical Trials Directory

Trials / Unknown

UnknownNCT02597218

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

Incidence of Venous Thromboembolic Disease and Portal Vein Thrombosis After Hepatectomy in a High-volume Center. A Cohort Study.

Status
Unknown
Phase
Study type
Observational
Enrollment
350 (estimated)
Sponsor
Hospital Italiano de Buenos Aires · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Timeline

Start date
2015-10-01
Primary completion
2019-10-01
Completion
2020-02-01
First posted
2015-11-05
Last updated
2019-08-13

Locations

1 site across 1 country: Argentina

Source: ClinicalTrials.gov record NCT02597218. Inclusion in this directory is not an endorsement.