Pulmonary Embolism After Liver Resection
This study is enrolling participants by invitation only.
Sponsor:
Beaujon Hospital
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
| Tracking Information | |||||
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| First Received Date ICMJE | December 4, 2011 | ||||
| Last Updated Date | December 5, 2011 | ||||
| Start Date ICMJE | January 2007 | ||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Pulmonary embolism [ Time Frame: up to January 2012 ] [ Designated as safety issue: Yes ] Blood clots in the lungs that may lead to sudden death. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01486511 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | |||||
| Original Other Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Pulmonary Embolism After Liver Resection | ||||
| Official Title ICMJE | Pulmonary Embolism After Liver Resection: A Prospective Analysis of Risk Factors | ||||
| 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. |
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| Detailed Description | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Biospecimen | |||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | All consecutive patients that will undergo liver resection for any type of liver disease. |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Group/Cohort (s) | Liver resection patients
All patients that underwent elective liver resection for both malignant and benign diseases.
Interventions:
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 500 | ||||
| Estimated Completion Date | January 2012 | ||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01486511 | ||||
| Other Study ID Numbers ICMJE | Beaujon | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Emmanuel Melloul, Beaujon Hospital | ||||
| Study Sponsor ICMJE | Beaujon Hospital | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Beaujon Hospital | ||||
| Verification Date | December 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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