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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02597218
Enrollment
350
Registered
2015-11-05
Start date
2015-10-31
Completion date
2020-02-29
Last updated
2019-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Portal Thrombosis, Pulmonary Embolism, Venous Thrombosis

Keywords

Hepatectomy, Prophylaxis

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.

Interventions

None listed

Sponsors

Hospital Italiano de Buenos Aires
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Venous thromboembolism (VTE)90 days following surgeryIncludes deep vein thrombosis (DVT) and pulmonary embolism (PE)

Secondary

MeasureTime frameDescription
Portal Thrombosis (PT)90 days following surgeryPortal thrombosis
Minor bleeding90 days following surgeryAny bleeding that doesn't fulfill major bleeding criteria.
Major bleeding90 days following surgeryAny 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

Countries

Argentina

Contacts

Primary ContactJuan Ignacio Trobbiani, Dr
juan.trobbiani@hospitalitaliano.org.ar+542914253231
Backup ContactJuan Cruz Iaquinandi, Dr
juan.iaquinandi@hospitalitaliano.org.ar011 69730105

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026