Skip to content

The Effect of Cyclosporine on Head Trauma

The effect of cyclosporine-A on neuro-recovery of diffuse axonal injury in comparison with placebo.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013011712164N1
Enrollment
100
Registered
2013-02-16
Start date
2012-03-19
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Axonal Injury. Diffuse Brain Injury

Interventions

Intervention 1: Cyclosporine-A, vial solution, 5mg/kg in 250 mili liter dextrose water 5% solution(DW5%) during the first 24hour of admission, one dose is administrated in all periods of the study.
Treatment - Drugs
Cyclosporine-A, vial solution, 5mg/kg in 250 mili liter dextrose water 5% solution(DW5%) during the first 24hour of admission, one dose is administrated in all periods of the study.
Intravenous, slow infusion of 250 mili liter of dextrose water 5% solution(DW5%) during the first 24hour of admission, that this solution is administrated one time in all periods of the study.

Sponsors

Vice chancellor for research, Isfahan University of Medical Science
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria are: Age between 16 and 75 years; GCS score less than 10 in 24 hours of admission; Complete consent form; ßHCG is negative and no pregnant patients. Exclusion criteria are: Negative brain stem reflex response; Patients with immune deficiency; Liver and kidney diseases; Penetrative brain injury; Multiple trauma; Past medical history of cancer; And patients that need emergency surgery; Pregnant women

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Level of Consciousness. Timepoint: 1day, 3month, 6month. Method of measurement: GCS, GOS-E, MMSE.

Secondary

MeasureTime frame
Liver Function Tests. Timepoint: 12hour, 24hour, 36hour, 48hour, 4day, 7day, 3month, 6month. Method of measurement: AST(Aspartat Aminotransferase), ALT(Alanine Aminotransferase), ALP(Alkaline Phosphatase).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Salman Abbasifard

Neurosurgery Department, Isfahan University of Medical Sciences

abbasi_fard@resident.mui.ac.ir+98 31 1668 5555

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026