RECRUITING

Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH)

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Conditions

Intracerebral HemorrhageMW01-6-189WHMW189Radiographic perihematomal edemaNeuroinflammationCerebral edema

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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

This first-in-patient phase 2a pilot study will assess the safety and tolerability of MW01-6-189WH (hereafter called MW189) in patients with Intracerebral Hemorrhage (ICH).

Official Title

Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH) Phase 2a Trial

Quick Facts

Study Start:2022-10-10
Study Completion:2026-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05020535

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. * Confirmed diagnosis of spontaneous, non-traumatic ICH.
  2. * 10 mL ≤ ICH ≤ 60 mL (confirmed via diagnostic and stability CT scans utilizing volumetric assessment)
  3. * Participants receiving anticoagulants are eligible upon reversal and stability within 24hrs after onset of ICH symptoms
  4. * Age ≥ 18 years
  5. * Able to receive first dose of test article ≤ 24h after onset of ICH symptoms
  6. * NIHSS score ≥ 2 at randomization or Glasgow Coma Scale ≥ 5 at randomization
  7. * Controlled blood pressure (systolic BP \< 180 mm Hg) at randomization.
  8. * Premorbid magnetic resonance spectroscopy (mRS) of 0-2
  9. * Has adequate venous access
  10. * No planned surgical intervention except EVD
  11. * Written informed consent from the patient or legally authorized representative (LAR)
  1. * Unstable hematoma defined as \> 6 mL increase as compared to previous CT volume taken at least 6 hours apart within 24 hrs after onset of ICH symptoms.
  2. * Anticipated neurosurgical evacuation by open surgery or minimally invasive surgery with or without Alteplase (EVD allowed).
  3. * Uncontrolled temp \>38.5˚C at enrollment.
  4. * Signs of intracranial infection or emergence of a systemic infection
  5. * Is pregnant or lactating
  6. * Signs of liver and kidney chronic disease (i.e. creatinine \>2, bilirubin \> 3, receiving dialysis)
  7. * Non-reversible bleeding diathesis
  8. * Used any chronic immunosuppressants or chronic anti-inflammatory drugs (excluding low-dose aspirin), by any route of administration within the past 7 days.
  9. * Anticipated withdrawal of life-sustaining therapies within the first week after admission.
  10. * In the opinion of the investigator, patient has any contraindication to the planned study assessments.
  11. * In the opinion of the investigator, patient has a condition that could interfere with the proposed treatment or unacceptably increase the individual's risk by participating in the study.
  12. * Concomitant enrollment in another acute interventional study

Contacts and Locations

Study Contact

Daniel Hanley
CONTACT
(410) 361-7999
dhanley@jhmi.edu
Cailin Brady
CONTACT
(443) 927-3970
whisle1@jh.edu

Principal Investigator

Linda Van Eldik
PRINCIPAL_INVESTIGATOR
University of Kentucky

Study Locations (Sites)

University of Alabama Birmingham
Birmingham, Alabama, 35294
United States
Stanford University
Palo Alto, California, 94304
United States
Yale New Haven Hospital
New Haven, Connecticut, 06511
United States
Cleveland Clinic Florida
Stuart, Florida, 34994
United States
University of Kentucky
Lexington, Kentucky, 40536
United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
University of New Mexico
Albuquerque, New Mexico, 87131
United States
New York University Grossman School of Medicine
Brooklyn, New York, 11220
United States
University of Cincinnati
Cincinnati, Ohio, 45219
United States
University of Texas Houston
Houston, Texas, 77030
United States
University of Texas San Antonio
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Linda Van Eldik, PRINCIPAL_INVESTIGATOR, University of Kentucky

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 Date2022-10-10
Study Completion Date2026-10-01

Study Record Updates

Study Start Date2022-10-10
Study Completion Date2026-10-01

Terms related to this study

Keywords Provided by Researchers

  • Intracerebral hemorrhage
  • MW01-6-189WH
  • MW189
  • Radiographic perihematomal edema
  • Neuroinflammation
  • Cerebral edema

Additional Relevant MeSH Terms

  • Intracerebral Hemorrhage