Characterization of Human Autoantibody Titers After Central Nervous System Insult (CHAT CNS)

Utah System of Higher Education (USHE)

Status: Terminated

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

Study type: Observational

Funder types: Other

Identifiers

NCT03089749

CHAT-00081214

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Exclusion criteria

• Participant who is pregnant

Trial design

63 participants in 4 patient groups

Control

Description:

Participants with no history of Traumatic Brain Injury, Traumatic Spinal Cord Injury or Intracranial Neoplasm. A single draw of 5 mL of blood will be obtained as well as demographic information and a brief medical history to act as comparison data to the other groups.

Traumatic Brain Injury (TBI)

Description:

Patients with Acute Severe TBI (post-resuscitation GCS of 8 or less). Participants will have blood draws at the time points identified below: * At 24h from the time of CNS insult * At 3, 5, 7, 10, 14, 18, 21, 30 days from the time of CNS insult * At 3, 6, and 12 months from the time of CNS insult * Annually for the next four years Total of up to 16 blood draws. In all cases, 5 mL of blood will be obtained from the participant. Demographic data will be collected, including: * Age * Sex * History of prior CNS insult * Clinical indicators of severity including baseline, post-resuscitation Glasgow Coma Scale (GCS) scores for brain injury patients * Radiographic indicators of severity including volume of intracranial hemorrhage, effacement of basal cisterns, amount of midline shift as well as Marshall and Rotterdam CT head scores for TBI. * Outcome data including discharge, 3-, 6-, and 12-month extended Glasgow Outcome Scale (GOS) scores

Spinal Cord Injury (SCI)

Description:

Patients with acute spinal cord injury (SCI) (post-resuscitation ASIA score of C, B or A). Participants will have blood draws at the time points identified below: * At 24h from the time of CNS insult * At 3, 5, 7, 10, 14, 18, 21, 30 days from the time of CNS insult * At 3, 6, and 12 months from the time of CNS insult * Annually for the next four years Total of up to 16 blood draws. In all cases, 5 mL of blood will be obtained. Demographic data will be collected, including: * Age * Sex * History of prior CNS insult * Clinical indicators of severity including baseline post-resuscitation American Spinal Injury Association (ASIA) score and ASIA impairment scale (AIS) grade for patients with spinal cord injury (SCI) * Radiographic indicators of severity including the degree of cord compression, area of cord signal change and the SFGH MRI scale will be employed. * Outcome data including discharge, 3-, 6-, and 12-month ASIA scores for SCI patients

Intracranial Neoplasm

Description:

Patients undergoing resection of intra-axial brain tumors (commonly gliomas such as glioblastoma multiforme, astrocytomas and oligodendrogliomas). All participants will have blood draws at the time points identified below: * At 24h from the time of CNS insult * At 3, 5, 7, 10, 14, 18, 21, 30 days from the time of CNS insult * At 3, 6, and 12 months from the time of CNS insult * Annually for the next four years Total of up to 16 blood draws. In all cases, 5 mL of blood will be obtained. Demographic data will be collected, including: * Age * Sex * History of prior CNS insult * Clinical indicators of severity including baseline, Karnofsky and Modified Rankin performance status scores for oncology patients. * Radiographic indicators of severity including the pre- and postoperative tumor volumes that will be quantitated. * Outcome data including discharge, 3-, 6-, and 12-month Karnofsky and Modified Rankin scores for oncology patients.