NCT01486511

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2011

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

December 6, 2011

Status Verified

December 1, 2011

Enrollment Period

5 years

First QC Date

December 4, 2011

Last Update Submit

December 5, 2011

Conditions

Liver DiseasePulmonary EmbolismThrombophiliaDeath

Keywords

Liver diseasePulmonary embolismThrombophiliaDeath

Outcome Measures

Primary Outcomes (1)

  • Pulmonary embolism

    Blood clots in the lungs that may lead to sudden death.

    up to January 2012

Secondary Outcomes (3)

  • Complications

    up to January 2012

  • Length of hospital stay

    up to January 2012

  • Mortality

    up to January 2012

Study Arms (1)

Liver resection patients

All patients that underwent elective liver resection for both malignant and benign diseases.

Procedure: Liver resectionRadiation: Computed Tomography

Interventions

Liver resectionPROCEDURE

Hepatectomy including both minor and major.

Also known as: Hepatectomy, liver resection
Liver resection patients
Computed TomographyRADIATION

Computed Tomography +/- pulmonary angiography

Also known as: CT, CTPA, CT-PA, MSCT, MSCT-PA
Liver resection patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive patients that will undergo liver resection for any type of liver disease.

You may qualify if:

  • Age \>18 years
  • Malignant liver diseases
  • Benign liver diseases

You may not qualify if:

  • Age \<18 years
  • Previous history of thromboembolic events
  • Living Donor hepatectomies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Jacques Belghiti

Paris, Clichy, 92110, France

Location

MeSH Terms

Conditions

Liver DiseasesPulmonary EmbolismThrombophiliaDeath

Interventions

Hepatectomy4-((1,4,8,11-tetraazacyclotetradec-1-yl)methyl)benzoic acid

Condition Hierarchy (Ancestors)

Digestive System DiseasesLung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesHematologic DiseasesHemic and Lymphatic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Jacques Belghiti, MD

    Beaujon Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, Surgeon

Study Record Dates

First Submitted

December 4, 2011

First Posted

December 6, 2011

Study Start

January 1, 2007

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

December 6, 2011

Record last verified: 2011-12

Locations

FR(1)