RECRUITING

PeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac Arrest

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Brain injury is the main cause of death and disability for patients surviving cardiac arrest resuscitation and seizures are diagnosed in up to a third of these patients. The investigators are proposing a pilot randomized placebo-controlled clinical trial to evaluate the safety and feasibility of perampanel use for post-cardiac arrest status epilepticus (PCARSE) prevention after cardiac arrest.

Official Title

PeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac Arrest

Quick Facts

Study Start:2024-05-20
Study Completion:2026-10-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06401707

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥18 years old
  2. * Non-traumatic, out-of-hospital cardiac arrest
  3. * Comatose on admission - defined as not following commands
  4. * Return of spontaneous circulation (ROSC) within less than 45 minutes from the time of cardiac arrest (defined as the time of 911 or EMS (emergency medical services) witnessed arrest)
  5. * Admission to the intensive care unit at Zuckerberg San Francisco General Hospital
  1. * Acute cerebral hemorrhage or infarction
  2. * Pregnancy
  3. * Prisoner
  4. * Severe kidney function impairment with creatinine clearance inferior to 30 ml/min
  5. * Severe liver impairment with liver function tests five times above the upper limit of normal
  6. * Electrographic or electroclinical seizures diagnosis using American Clinical Neurophysiology criteria confirmed by an epileptologist after cardiac arrest

Contacts and Locations

Study Contact

Edilberto Amorim, MD
CONTACT
628-206-3203
prosperstudy@ucsf.edu
Kevin Bao, BA
CONTACT
prosperstudy@ucsf.edu

Principal Investigator

Edilberto Amorim, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Edilberto Amorim, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-20
Study Completion Date2026-10-20

Study Record Updates

Study Start Date2024-05-20
Study Completion Date2026-10-20

Terms related to this study

Keywords Provided by Researchers

  • heart arrest
  • seizure
  • status epilepticus
  • prophylaxis

Additional Relevant MeSH Terms

  • Heart Arrest
  • Seizures
  • Status Epilepticus