Yttrium-90 Radioembolization for Cirrhosis-Associated Thrombocytopenia

  • STATUS
    Recruiting
  • End date
    Apr 1, 2024
  • participants needed
    20
  • sponsor
    Northwestern University
Updated on 25 February 2022
platelet count
hypertension
electrolytes
carcinoma
venous pressure
cirrhosis
hepatocellular carcinoma
varices
varicose veins
hepatic venous pressure gradient
gastric varices
biopsy of liver

Summary

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

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.

Details
Condition Thrombocytopenia, Cirrhosis
Treatment TheraSphere® Yttrium-90 Glass Microspheres, BTG International Inc.
Clinical Study IdentifierNCT03059030
SponsorNorthwestern University
Last Modified on25 February 2022

Eligibility

Yes No Not Sure

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
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