yttrium-90 radioembolization for cirrhosis-associated thrombocytopenia

Conditions: Thrombocytopenia; Cirrhosis

Summary: evaluate the safety and efficacy of yttrium-90 (90y) radioembolization for the management of thrombocytopenia.

this protocol will provide access to therasphere® treatment for patients who have refractory thrombocytopenia secondary to cirrhosis. this protocol will utilize splenic artery-directed therasphere® treatment.

Eligibility criteria:
inclusion criteria: * male or female, 18 years of age or older, of any ethnic or racial group. * diagnosis of cirrhosis or portal hypertension with a serum platelet count less than or equal to 80 × 109/l. \[rationale: platelet count \<100 × 109/l triples the rate of liver-related adverse events (3) and worsens postoperative survival in the setting of hepatocellular carcinoma (hcc) (4). initial platelet count of 80 × 109/l can allow the majority of patients who successfully respond to 90y-re (clinical endpoint of 50% platelet count increase) to exceed the 100 × 109/l threshold.\] cirrhosis is defined by one of three criteria: * liver biopsy/histology consistent with cirrhotic architectural liver changes * portal hypertension (hepatic venous pressure gradient ≥10 mm hg) * evidence of esophageal and/or gastric varices * patients must have evidence of splenomegaly as determined by screening cross-sectional imaging. * no evidence of myelosuppression (e.g. lymphopenia) as evidenced by normal hematology values at screening * adequate baseline organ function(with the exception of cirrhosis) as evidenced by normal bun/cr and electrolytes on screening chemistry. * eastern cooperative oncology group (ecog) performance status score of 0-2 * patient has a life expectancy of greater than 6 months without intervention. * patient is willing to participate in the study and has signed the study informed consent. * women of childbearing potential must have a negative serum pregnancy test within 28 days prior to screening and must not be breastfeeding. exclusion criteria: * patients with serum platelet count less than 10 × 109/l. * history of bleeding disorder attributed to another cause other than cirrhosis (e.g. von willebrand disease) * declines or unable to provide informed consent * history of prior partial splenic embolization (pse) or splenectomy * use of any medication known to increase platelet count 1 month prior to baseline. * history of allergy or sensitivity to therasphere® or its components. * history of severe peripheral allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically * contraindications to angiography and selective visceral catheterization such as bleeding, diathesis or coagulopathy that is not correctable by usual therapy or hemostatic agents (e.g. closure device) * previous randomization in a trial using 90y re * patient must not have participated or enrolled in a clinical trial with an investigational device / therapy within 30 days prior to randomization * any serious medical condition likely to impede successful completion of the study, such as certain mental disorders, cardiac arrhythmias, and uncontrolled congestive heart failure or respiratory disease. * patients actively on chemotherapy.

Keywords: thrombocytopenia cirrhosis therasphere® y90 radioembolization