Trial record 8 of 81 for:    "Thrombophilia" OR "prothrombin thrombophilia"

Pulmonary Embolism After Liver Resection

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Emmanuel Melloul, Beaujon Hospital
ClinicalTrials.gov Identifier:
NCT01486511
First received: December 4, 2011
Last updated: December 5, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Liver Disease
Pulmonary Embolism
Thrombophilia
Death
Procedure: Liver resection
Radiation: Computed Tomography

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pulmonary Embolism After Liver Resection: A Prospective Analysis of Risk Factors

Resource links provided by NLM:


Further study details as provided by Beaujon Hospital:

Primary Outcome Measures:
  • Pulmonary embolism [ Time Frame: up to January 2012 ] [ Designated as safety issue: Yes ]
    Blood clots in the lungs that may lead to sudden death.


Secondary Outcome Measures:
  • Complications [ Time Frame: up to January 2012 ] [ Designated as safety issue: Yes ]
    Any type of post-operative complications graded according to the Clavien-Dindo Classification of Surgical Complications

  • Length of hospital stay [ Time Frame: up to January 2012 ] [ Designated as safety issue: No ]
    The duration of hospitalization in days.

  • Mortality [ Time Frame: up to January 2012 ] [ Designated as safety issue: Yes ]
    Post-operative 90-Day Mortality


Estimated Enrollment: 500
Study Start Date: January 2007
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Liver resection patients
All patients that underwent elective liver resection for both malignant and benign diseases.
Procedure: Liver resection
Hepatectomy including both minor and major.
Other Name: Hepatectomy, liver resection
Radiation: Computed Tomography
Computed Tomography +/- pulmonary angiography
Other Name: CT, CTPA, CT-PA, MSCT, MSCT-PA

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Age <18 years
  • Previous history of thromboembolic events
  • Living Donor hepatectomies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01486511

Locations
France
Prof. Jacques Belghiti
Paris, Clichy, France, 92110
Sponsors and Collaborators
Beaujon Hospital
Investigators
Principal Investigator: Jacques Belghiti, MD Beaujon Hospital
  More Information

No publications provided

Responsible Party: Emmanuel Melloul, Medical Doctor, Surgeon, Beaujon Hospital
ClinicalTrials.gov Identifier: NCT01486511     History of Changes
Other Study ID Numbers: Beaujon
Study First Received: December 4, 2011
Last Updated: December 5, 2011
Health Authority: France: Institutional Ethical Committee

Keywords provided by Beaujon Hospital:
Liver disease
Pulmonary embolism
Thrombophilia
Death

Additional relevant MeSH terms:
Thrombophilia
Death
Embolism
Liver Diseases
Pulmonary Embolism
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Hematologic Diseases
Liver Extracts
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014