VALIDATE: Factor VIII Trending for MS Relapse

NCT04082468 | Withdrawn

• 1 other identifier: 18-500-440-30-10
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Multiple Sclerosis

Keywords

Relapsing remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Correlation of MS relapse recovery time with elevated lab values.

  Extent of relapse recovery across a variety of measures will be correlated with collected lab values and neurological assessments in an attempt to identify a positive correlation between incomplete recovery and solumedrol resistance with abnormally elevated lab values involving the vWF antigen and Factor VIII pathways

  180 days

Interventions

Blood sample collection for coagulation profile DIAGNOSTIC_TEST

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

Also known as: Clinical data collection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute MS relapse patients hospitalized at St. Joseph's Hospital and Medical Center in Phoenix, Arizona

You may qualify if:

• Adult patients aged 18-65 with an established diagnosis of relapsing remitting multiple sclerosis (RRMS);
• Patients with RRMS hospitalized at St. Joseph's Hospital and Medical Center in Phoenix, Arizona for an acute relapse affecting strength or vision;
• Patients may or may not be on disease modifying treatment;
• Entry EDSS score up to 7.0.

You may not qualify if:

• Patients unable to have an MRI;
• Patients taking any heparin products, warfarin (Coumadin), apixiban (Eliquis), dabigatran (Pradaxa), or rivaroxaban (Xarelto);
• If stroke, tumor or other non-MS related cause is identified as the source of the patient's neurological issues.

Sponsors & Collaborators

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

Study Sites (1)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting

Interventions

Bleeding Time

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Platelet Function Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Amiee Borazanci, MD

  St. Joseph's Hospital/Barrow Neurological Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 9, 2019
• Study Start: August 13, 2019
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)