Lycopene Following Aneurysmal Subarachnoid Haemorrhage

Subarachnoid Hemorrhage Clinical Trial

— LASH  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00905931
• Other study ID #: LASH 3
• Status: Not yet recruiting
• Phase: Phase 2
• First received: May 19, 2009
• Last updated: June 10, 2010
• Start date: September 2010
• Est. completion date: October 2012

Study information

• Verified date: June 2010
• Source: University of Cambridge
• Contact: Karol P Budohoski, MD
• Phone: (0044)1223331763
• Email: kpb26[@]cam.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 124
• Est. completion date: October 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Aneurysm
• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Drug:
• Lycopene
30 mg oral, daily, for 21 days
• placebo
starch

Locations

Country	Name	City	State
United Kingdom	Addenbrooke's Hospital	Cambridge	Cambridgeshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Cambridge	Cambridge Theranostics Ltd

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Verghese M, Sunkara R, Shackelford L, Walker LT. Lycopene and cardiovascular diseases. In Preedy VR, Watson RR Ed. Lycopene: nutritional, medicinal and therapeutic properties. Science Publishers, New Hampshire, USA 2008.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of vasospasm	Mean flow velocity in MCA > 120 cm/min; LR > 3 (4 if age < 50 years old)	Daily for 21 days	No
Primary	Duration of impaired autoregulation measured with transcranial Doppler	Transient hyperaemic response test; Mx	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