Lycopene Following Aneurysmal Subarachnoid Haemorrhage "LASH"

Not yet recruiting

Phase 2 Results N/A

Trial Description

In this study the investigators wish to explore the potential neuroprotective effects of acute oral supplementation of lycopene, a natural anti-oxidant derived from tomatoes, on cerebral vasospasm and autoregulation, and examine whether any improvements translate into a reduction of biochemical markers of vascular injury and inflammation a decrease in the prevalence of secondary strokes following subarachnoid haemorrhage.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: starch
    ARM 1: Kind: Experimental
    Label: Placebo
  • Lycopene Drug
    Intervention Desc: 30 mg oral, daily, for 21 days
    ARM 1: Kind: Experimental
    Label: Active

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized to one of two arms: Lycopene 30 mg oral, daily, for 21 days or placebo orally daily for 21 days.

Outcomes

Type Measure Time Frame Safety Issue
Primary Incidence of vasospasm Duration of impaired autoregulation on TCD
Primary Incidence of vasospasm Daily for 21 days No
Primary Duration of impaired autoregulation measured with transcranial Doppler Daily for 21 days No
Secondary Level of biochemical markers of vascular injury: LDL, oxy-LDL, CRP, circulating endothelial cells, endothelial progenitor cells Days: 0, 3, 6, 12, 14, 21 No

Sponsors