Pulmonary Embolism After Liver Resection

Pulmonary Embolism Clinical Trial

Official title:

Pulmonary Embolism After Liver Resection: A Prospective Analysis of Risk Factors

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01486511
• Other study ID #: Beaujon
• Status: Unknown status
• Phase: N/A
• First received: December 4, 2011
• Last updated: December 5, 2011
• Start date: January 2007
• Est. completion date: January 2012

Study information

• Verified date: December 2011
• Source: Beaujon Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Major surgery is associated with a postoperative hypercoagulable state related to the surgical trauma that may lead to thromboembolic complications. To the investigators knowledge, only two series have reported the risk of PE after liver surgery with an incidence of up to 6.3% The purpose of this study is to identify the independent risk factors associated with the development of PE after elective liver surgery.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 500
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 years

• Malignant liver diseases

• Benign liver diseases

Exclusion Criteria:

• Age <18 years

• Previous history of thromboembolic events

• Living Donor hepatectomies

Related Conditions & MeSH terms

• Death
• Embolism
• Liver Disease
• Liver Diseases
• Pulmonary Embolism
• Thrombophilia

Intervention

Procedure:
• Liver resection
Hepatectomy including both minor and major.

Radiation:
• Computed Tomography
Computed Tomography +/- pulmonary angiography

Locations

Country	Name	City	State
France	Prof. Jacques Belghiti	Paris	Clichy

Sponsors (1)

Lead Sponsor	Collaborator
Beaujon Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary embolism	Blood clots in the lungs that may lead to sudden death.	up to January 2012
Secondary	Complications	Any type of post-operative complications graded according to the Clavien-Dindo Classification of Surgical Complications	up to January 2012
Secondary	Length of hospital stay	The duration of hospitalization in days.	up to January 2012
Secondary	Mortality	Post-operative 90-Day Mortality	up to January 2012