Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
NCT ID:
NCT03532750
Eligibility Criteria:
Inclusion Criteria:
* • Patients who are between 22-70 years of age.
* Patient must have portal hypertension; as defined by: refractory ascites or unilateral right sided pleural effusions with concomitant liver cirrhosis and splenomegaly (spleen \> 11 cm on CT or US).
* Medically refractive/intolerant, ascites or unilateral right sided pleural effusions consistent with hepatic hydrothorax. Medically refractive defined as those with persistent need for paracentesis or thoracentesis despite maximal doses of diuretics (400 mg spironolactone and 160 mg furosemide per day) or those who are intolerant of furosemide (develop azotemia, electrolyte imbalance, encephalopathy or renal failure) or spironolactone (develop gynecomastia, decreased libido, and hyperkalemia).
* Patients will need to meet one or more of the following requirements:
* MELD \>18 but \<35
* Anatomic variation making TIPS impossible/difficult
* Previous failed attempt to place TIPS
* Unwilling to undergo TIPS
* History of severe hepatic encephalopathy
* Thrombosis of the hepatic veins
* Willing and able to provide informed consent
Exclusion Criteria:
* Patients \< 22 and \>70 years of age
* Patients with CLDQ score of \>6 or \<2
* Patients with a weight \>400 pounds
* Patients with primary or secondary splenic cancer
* Currently pregnant
* Current systemic infection
* Patients who have undergone prior splenectomy or other splenic surgery
* Patients who have previously undergone splenic artery embolization for any reason (likely reasons would be trauma or thrombocytopenia)
* Patients with splenic vascular anatomy that would increase the risk of non-target embolization.
* Patients who have a INR or platelet count which are not correctable to \<1.8 and \>35,000 respectively
* Anaphylaxis to intravenous contrast.
* Patients diagnosed with Budd-Chiari Syndrome (This will be assessed on pre-intervention CTA)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
70 Years
Study:
NCT03532750
Study Brief:
Protocol Section:
NCT03532750