Yttrium-90 Radioembolization for Cirrhosis-Associated Thrombocytopenia

Northwestern University

Status

Active, not recruiting

Conditions

Thrombocytopenia

Cirrhosis

Treatments

Device: TheraSphere® Yttrium-90 Glass Microspheres, BTG International Inc.

Study type

Interventional

Funder types

Other

Identifiers

NCT03059030

STU 00203772

Details and patient eligibility

About

Evaluate the safety and efficacy of Yttrium-90 (90Y) radioembolization for the management of thrombocytopenia.

Full description

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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.