Characterization of Human Autoantibody Titers After Central Nervous System Insult

Terminated

• Conditions: Spinal Cord Trauma; Intracranial Neoplasm; Brain Injuries, Traumatic

• Registration Number: NCT03089749
• Lead Sponsor: University of Utah

Brief Summary

The aim of the study is to quantitate Central Nervous System (CNS) autoantibody development in human blood using ELISA after human brain injury, spinal cord injury, and intra-axial brain surgeries.

Detailed Description

Study Objectives:

We aim to:

1. Quantitate CNS autoantibody development in human blood using ELISA after human brain injury, spinal cord injury, and intra-axial brain surgeries. We also aim to characterize the temporal course of this response.

2. Characterize how CNS autoantibody levels correlate with specific injury patterns as well as radiographic and clinical measures of injury severity.

3. Determine how intercurrent infection and a history of prior CNS insult affects the temporal course and magnitude of autoantibody production.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2017-03-17
• Study First Submitted QC: 2017-03-17
• Study First Posted: 2017-03-24
• Primary Completion: 2019-05-20
• Study Completion: 2019-05-20
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• Have a severe traumatic brain injury
• Have spinal cord injury ASIA grade A, B or C
• Undergoing resection of intra-axial brain tumors

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Exclusion Criteria

• Participant who is pregnant

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantitate Autoantibodies	5 years	Quantitate CNS autoantibody development and temporal course in human blood using ELISA after human brain injury, spinal cord injury, and intra-axial brain surgeries.

Secondary Outcome Measures

Name	Time	Method
Autoantibody Correlation	5 years	Characterize how CNS autoantibody levels correlate with specific injury patterns as well as radiographic and clinical measures of injury severity.
Autoantibody Production and History	5 years	Determine how intercurrent infection and a history of prior CNS insult affects the temporal course and magnitude of autoantibody production.

Trial Locations

Locations (1)

University of Utah Hospital; 🇺🇸 Salt Lake City, Utah, United States