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Proposal 1180

Title of the Proposed Research

Evaluation of a platelet count threshold for bleeding risk in thrombocytopenic patients with chronic liver disease who undergo diagnostic and therapeutic invasive procedures.

Lead Researcher

Edoardo G. Giannini

Affiliation

Department of Internal Medicine, University of Genoa, Genoa, Italy.

Funding Source

None

Potential Conflicts of Interest

Consultancies: GSK

Data Sharing Agreement Date

12 December 2016

Lay Summary

This research needs to be done because, despite advancement in current knowledge, the threshold for platelet transfusion in patients with liver disease is not known.

This issue is relevant, as unnecessary transfusions (i.e., transfusions perfomed in patients who are not at risk of bleeding) may expose patients to transfusion-related risks though they do not require this practice. Furthermore, performing selective rather than acritical transfusions in patients who are at higher risk might make platelet transfusions more readily available to patients who are in the need of being transfused.

The aim of this study will be to identify if, among patients who have a similar degree of severity of disase, a subgroup of patients may avoid to be transfused without running the risk of bleeding.

The research will be conducted on data that are already available. The desing of the study will not take into account various arms according to the fact that in some patients a drug was used to increase platelet counts, as we will examine the actual platelet count of the day of the invasive procedure, regardless of how that platelet count was reached.

Application of statistics will identify a platelet count cut-off above which performing invasive manouvres can be regarded as a safe procedure even in patients with decreased platelet count.

The result of this study will not only help plan better studies in the future, but will also

Study Data Provided

NOVARTIS-TPL104054: Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Study to Evaluate the Safety and Efficacy of Eltrombopag to Reduce the Need for Platelet Transfusion in Thrombocytopenic Subjects with Chronic Liver Disease Undergoing Elective Invasive Procedures

Statistical Analysis Plan

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.