Evaluation of Efficacy and Safety of Somatostatin Used as Inflow Modulator in Liver Transplantation.
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ClinicalTrials.gov Identifier: NCT01290172 |
Recruitment Status
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Completed
First Posted
: February 4, 2011
Last Update Posted
: December 2, 2014
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Tracking Information | ||||
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First Submitted Date ICMJE | February 3, 2011 | |||
First Posted Date ICMJE | February 4, 2011 | |||
Last Update Posted Date | December 2, 2014 | |||
Study Start Date ICMJE | December 2010 | |||
Actual Primary Completion Date | December 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Evaluation of safety and efficacy using Somatostatin. [ Time Frame: 5 days ] To evaluate the safety and efficacy, using Somatostatin as portal vein flow and pressure modulator in liver transplantation in humans. Hepatic and systemic hemodynamic measurements will be recorded prior, during and after the bolus infusion of Somatostatin/Placebo during liver transplantation. Infusion of Somatostatin/Placebo will be continued for 5 days.
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01290172 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Evaluation of Efficacy and Safety of Somatostatin Used as Inflow Modulator in Liver Transplantation. | |||
Official Title ICMJE | A Single-center, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Somatostatin Used as Inflow Modulator in Liver Transplantation. | |||
Brief Summary | This study is a 5 day, single-center, randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of Somatostatin used as inflow modulator in liver transplantation. Patient systemic and hepatic dynamics will be collected and recorded at predefined time-points. To evaluate the ischemia-reperfusion injury, it is planned to perform liver biopsies at two different time-points to compare the liver structure and proteomic variations. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Liver Transplant With Clinically Significant Portal Hypertension | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* 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 | Completed | |||
Actual Enrollment ICMJE |
33 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | January 2014 | |||
Actual Primary Completion Date | December 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 70 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01290172 | |||
Other Study ID Numbers ICMJE | 2008/689 2008-008319-24 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | University Hospital, Ghent | |||
Study Sponsor ICMJE | University Hospital, Ghent | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | University Hospital, Ghent | |||
Verification Date | November 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |