In this research proposal the MGH Investigators seek to become one of the Core Clinical Centers in the Transfusion Medicine/Hemostasis Clinical Research Network through which many clinically important problems will be answered by multi-center, collaborative research. The proposed MGH Transfusion Medicine/Hemostasis Clinical Research Center would be comprised of four senior investigators with extensive research experience who have collaborated on many prior trials and who represent transfusion medicine, adult hemostasis, and pediatric hemostasis. The Center would also have two dedicated Research Nurses with extensive experience in transfusion medicine/hemostasis clinical trials. A major aim of the MGH Center would be to train new investigators in this area. The proposed MGH Transfusion Medicine/Hemostasis Clinical Research Center would agree to participate in the protocols approved by the Steering Committee and submits two research trials for consideration. The first study is to determine if the frequency of hemorrhagic complications among patients undergoing an invasive hepatobiliary procedure is reduced by pre-procedure treatment with FFP or recombinant factor VIIa (rVIIa). Despite the lack of any proven benefit, enormous amounts of FFP are used in an attempt to "normalize" the prothrombin time (PT) pre-procedure in patients with liver disease. In this study patients with elevated PT would be randomized to FFP or rVIIa pre-procedure and the extent of bleeding at biopsy would be assessed with CT scan and CBC. In a subset of patients, no treatment would be given. The results obtained should indicate whether (a) pre-treatment coagulation tests predict bleeding, (b) pre-procedure treatment with FFP or rVIIa affects these tests, (c) whether bleeding at procedure is reduced. The second proposal seeks to assess whether recombinant human thrombopoietin (rHuTPO) is more effective than IVIG in preparing chronic ITP patients for splenectomy. About 50% of adults with chronic ITP eventually undergo splenectomy. Although there is no "standard" pre-operative treatment, IVIG is routinely given to boost counts transiently for surgery. In the proposed study, patients scheduled for splenectomy will be randomized to a single intravenous dose of rHuTPO or IVIG and their platelet count response and "operability" determined subsequently. A cross-over design would allow patients failing one initial therapy to receive the other treatment. Study endpoints would include (a) the percentage of patients increasing the platelet count over 50x109/L, (b) the number of RBC and platelet transfusions at splenectomy, (c) the rate of adverse events.
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