Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2026-03-01 @ 9:58 AM
Study NCT ID:
NCT02597218
Status:
UNKNOWN
Last Update Posted:
2019-08-13
First Post:
2015-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence of Venous Thromboembolic Disease and Portal Vein Thrombosis After Hepatectomy. A Cohort Study.
Sponsor:
Hospital Italiano de Buenos Aires
Organization:
Study Overview
Official Title:
Incidence of Venous Thromboembolic Disease and Portal Vein Thrombosis After Hepatectomy in a High-volume Center. A Cohort Study.
Status:
UNKNOWN
Status Verified Date:
2019-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: