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

NCT02597218 | Unknown DMC

• 1 other identifier: 2611
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

Observational. Retrospective cohort.

Conditions

Pulmonary Embolism; Venous Thrombosis; Portal Thrombosis

Keywords

Hepatectomy; Prophylaxis

Outcome Measures

Primary Outcomes (1)

• Venous thromboembolism (VTE)

  Includes deep vein thrombosis (DVT) and pulmonary embolism (PE)

  90 days following surgery

Secondary Outcomes (3)

• Portal Thrombosis (PT)

  90 days following surgery

• Minor bleeding

  90 days following surgery

• Major bleeding

  90 days following surgery

Study Arms (1)

Patients following hepatectomy

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients older than 18 years following hepatectomy of any kind for oncologic/non-oncologic disease between 04/09/2012 and 08/28/2015 were enrolled. Follow-up concluded 90 days after surgery or at occurence of event (Venous thromboembolism / portal thrombosis / death).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Hospital Italiano de Buenos Aires

Capital Federal, Buenos Aires, 1170, Argentina

RECRUITING

Related Publications (20)

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  PMID: 22762398 BACKGROUND

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MeSH Terms

Conditions

Pulmonary Embolism; Venous Thrombosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis

Study Officials

• Martín de Santibañes, Dr

  Hospital Italiano de Buenos Aires

  STUDY DIRECTOR

Central Study Contacts

Juan Ignacio Trobbiani, Dr

CONTACT

+542914253231; juan.trobbiani@hospitalitaliano.org.ar

Juan Cruz Iaquinandi, Dr

CONTACT

011 69730105; juan.iaquinandi@hospitalitaliano.org.ar

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: November 5, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2019
• Study Completion: February 1, 2020
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

AR (1)