Prediction of Mortality in Patients Waiting for Liver Transplantation Through Brain Magnetic Resonance Imaging
| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2011 | ||||
| Last Updated Date | September 13, 2011 | ||||
| Start Date ICMJE | November 2011 | ||||
| Estimated Primary Completion Date | November 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Mortality [ Time Frame: Three months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Prediction of Mortality in Patients Waiting for Liver Transplantation Through Brain Magnetic Resonance Imaging | ||||
| Official Title ICMJE | Prediction of Mortality in Patients Waiting for Liver Transplantation Through Brain Magnetic Resonance Imaging | ||||
| Brief Summary | The purpose of this study is to determine whether hepatic encephalopathy, measured through magnetic resonance imaging, electroencephalogram and neuropsychological evaluation adds prognostic information to patients who are waiting for liver transplantation. If this model improves mortality prediction this might be used in the future for organ allocation. |
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| Detailed Description | The only current definitive treatment for end-stage liver disease is transplantation. Due to the scarcity of organs available, the correct prioritization of patients for liver transplantation has a crucial importance. Nowadays, patients are ranked according to severity of liver disease, measured by the MELD score. This index is only derived from objective measures (serum concentration of bilirubin, creatinine and INR). Hepatic encephalopathy (HE) is a serious and progressive disorder in patients with end-stage liver disease. The severity of HE has prognostic implications in those waiting for liver transplantation. However, the prognosis of HE is independent and not correlated to the MELD score. Hepatic encephalopathy triggers multiple changes in brain magnetic resonance imaging (MRI) providing an objective way to evaluate it. Also electroencephalogram and neuropsychological evaluation might increase mortality prediction. Adding the information provided by MRI, electroencephalogram and neuropsychological evaluation to the MELD score model might increase the prediction of mortality. Increase mortality's prediction has a fundamental importance because in organ allocation. We will evaluate the predictive value of these variables in predicting mortality of those patients waiting for liver transplantation. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients waiting for liver transplantation with chronic end stage liver disease. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Liver transplantation waiting list
Patients waiting for liver transplantation with chronic end staged liver disease |
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| Publications * | Habib S, Berk B, Chang CC, Demetris AJ, Fontes P, Dvorchik I, Eghtesad B, Marcos A, Shakil AO. MELD and prediction of post-liver transplantation survival. Liver Transpl. 2006 Mar;12(3):440-7. | ||||
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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 | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 400 | ||||
| Estimated Completion Date | February 2015 | ||||
| Estimated Primary Completion Date | November 2014 (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 |
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| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01434056 | ||||
| Other Study ID Numbers ICMJE | 1341-11, CEP1572 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Ellison Fernando Cardoso, Hospital Israelita Albert Einstein | ||||
| Study Sponsor ICMJE | Hospital Israelita Albert Einstein | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Hospital Israelita Albert Einstein | ||||
| Verification Date | September 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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