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

Study Overview
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Brief Summary
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Observational. Retrospective cohort.

Detailed Description
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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.

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

Conditions
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Pulmonary Embolism, Venous Thrombosis, Portal Thrombosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older than 18 years old. Following hepatic surgery. Exclusion Criteria: Living donor Venous thromboembolism within 6 months previous to surgery.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients following hepatectomy<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous thromboembolism (VTE) | Includes deep vein thrombosis (DVT) and pulmonary embolism (PE) | 90 days following surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Portal Thrombosis (PT) | Portal thrombosis | 90 days following surgery | 
| Minor bleeding | Any bleeding that doesn't fulfill major bleeding criteria. | 90 days following surgery | 
| Major bleeding | 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 | 90 days following surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatectomy, Prophylaxis