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VALIDATE: Factor VIII Trending for MS Relapse

NCT04082468 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2021-09-21

No results posted yet for this study

Summary

Multiple sclerosis (MS) patients hospitalized with an acute motor or visual relapse will be consented. Factor VIII-related labs will be systematically drawn for six months. During this time, patients will be followed with clinical assessments including: Expanded Disability Status Scale (EDSS), Multiple Sclerosis Functional Composite (MSFC), Low Contrast Sloan Letter Chart Testing, Symbol Digital Modality Test (SDMT), and NeuroQol. MRIs of the brain, cervical spine, and thoracic spine with and without contrast will be obtained. All patients will be treated with 1 gram IV solumedrol daily for five days per standard care. Clinical, imaging, and Factor VIII-related lab data individually or in aggregate will be correlated with relapse presence, severity, and extent of recovery following standard intravenous (IV) solumedrol treatment

Conditions

Interventions

DIAGNOSTIC_TEST

Blood sample collection for coagulation profile

Factor VIII Activity Level, Factor VIII Antigen Level, Interleukin 6, vWF Antigen Level, Thrombin Activity, Protein C Activity, Protein C Antigen Level, CRP, PT/PTT/INR ,T \& B lymphocyte panel at above time points

Sponsors & Collaborators

  • St. Joseph's Hospital and Medical Center, Phoenix

    lead OTHER

Principal Investigators

  • Amiee Borazanci, MD · St. Joseph's Hospital/Barrow Neurological Institute

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-13
Primary Completion
2021-12-01
Completion
2022-03-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04082468 on ClinicalTrials.gov