Lycopene Following Aneurysmal Subarachnoid Haemorrhage

Acute Oral Lycopene Therapy on Cerebral Autoregulation and Delayed Ischaemic Deficits Following Aneurysmal Subarachnoid Haemorrhage (LASH): A Randomized Controlled Trial

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00905931

Acronym

LASH

Enrollment

124

Registered

2009-05-21

Start date

2010-09-30

Completion date

2012-10-31

Last updated

2010-06-11

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

Conditions

Aneurysm, Subarachnoid Hemorrhage

Keywords

Aneurysmal subarachnoid hemorrhage (aSAH), Cerebral vasospasm, impaired cerebral autoregulation, transient hyperaemic response test, delayed ischaemic neurological deficits

Brief summary

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.

Interventions

DRUGLycopene

30 mg oral, daily, for 21 days

DRUGplacebo

starch

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age: \> 18 years old, * Confirmed aneurysmal subarachnoid hemorrhage (aSAH), * Time from ictus \< 96 hours

Exclusion criteria

* Age: \< 18 years old, * Non-aneurysmal SAH, * Time from ictus \> 96 hours, * Severe carotid atherosclerotic disease (≥70%) * High-dose statin therapy (\>80 mg/day fluvastatin; \>40 mg/day simvastatin; \>40 mg/day pravastatin; \>10 mg/day atorvastatin; \>10 mg/day rosuvastatin 28), * Allergy or hypersensitivity to tomatoes and tomato products and history of any other significant atopy/allergy (e.g. soy, whey, lutein, lecithin)

Design outcomes

Primary

Measure	Time frame	Description
Incidence of vasospasm	Daily for 21 days	Mean flow velocity in MCA \> 120 cm/min; LR \> 3 (4 if age \< 50 years old)
Duration of impaired autoregulation measured with transcranial Doppler	Daily for 21 days	Transient hyperaemic response test; Mx

Secondary

Measure	Time frame
Level of biochemical markers of vascular injury: LDL, oxy-LDL, CRP, circulating endothelial cells, endothelial progenitor cells	Days: 0, 3, 6, 12, 14, 21

Countries

United Kingdom

Contacts

Primary ContactKarol P Budohoski, MD

kpb26@cam.ac.uk(0044)1223331763

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026