Intravenous Immunoglobulin (IVIg) in Spinal Cord Injury

Phase 1

Recruiting

• Conditions: Spinal Cord Injury; Injuries and Accidents - Other injuries and accidents; Neurological - Other neurological disorders

• Registration Number: ACTRN12616001385437
• Lead Sponsor: niversity of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Acute traumatic cervical or thoracic spinal cord injury (up to T9).
Initiation of IVIg treatment must be within 12 hours of injury.

Exclusion Criteria

1.Known hypersensitivity to Privigen
2.History of significant cardiovascular, liver or kidney disease
3.Unconscious
4.Penetrating spinal cord injury
5.Involvement in another SCI research project
6.Presence of a mental disorder or other illness, which, in the view of the Principle Investigator (or their delegate) precludes informed consent and/or accurate medical evaluation.
7.Patients with history of regular substance abuse
8.Inability to commit or be available for follow-ups.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To obtain exploratory data on the efficacy of IVIg infusion in patients with acute traumatic spinal cord injury. The functional outcome will be assessed via:<br><br>a) ASIA examinations (standard neurological assessment tool) to assess neurological (sensory and motor) impairment at set intervals post-accident<br>b) SCIM (Spinal Cord Independence Measure) questionnaires, which assess both function and independence.<br>[The severity and level of neurological impairment for each study participant will be assessed upon admission, and then again at day 1, 3, 7, 21, 42 post-injury and at patient discharge (~12 months post-injury) from the Princess Alexandra Hospital, Brisbane.]