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Lycopene Following Aneurysmal Subarachnoid Haemorrhage (LASH)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by University of Cambridge.
Recruitment status was:  Not yet recruiting
Cambridge Theranostics Ltd
Information provided by:
University of Cambridge Identifier:
First received: May 19, 2009
Last updated: June 10, 2010
Last verified: June 2010
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.

Condition Intervention Phase
Subarachnoid Hemorrhage
Drug: Lycopene
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Acute Oral Lycopene Therapy on Cerebral Autoregulation and Delayed Ischaemic Deficits Following Aneurysmal Subarachnoid Haemorrhage (LASH): A Randomized Controlled Trial

Resource links provided by NLM:

Further study details as provided by University of Cambridge:

Primary Outcome Measures:
  • Incidence of vasospasm [ Time Frame: 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 [ Time Frame: Daily for 21 days ]
    Transient hyperaemic response test; Mx

Secondary Outcome Measures:
  • Level of biochemical markers of vascular injury: LDL, oxy-LDL, CRP, circulating endothelial cells, endothelial progenitor cells [ Time Frame: Days: 0, 3, 6, 12, 14, 21 ]

Estimated Enrollment: 124
Study Start Date: September 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Drug: Lycopene
30 mg oral, daily, for 21 days
Placebo Comparator: Placebo Drug: placebo


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
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Please refer to this study by its identifier: NCT00905931

Contact: Karol P Budohoski, MD (0044)1223331763 ext 72831763

United Kingdom
Addenbrooke's Hospital Not yet recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Contact: Peter J Kirkpatrick, FRCS(SN)    (0044)1223245151   
Contact: Karol P Budohoski, MD    (0044)1223 331763   
Sponsors and Collaborators
University of Cambridge
Cambridge Theranostics Ltd
Principal Investigator: Peter J Kirkpatrick, FRCS(SN) Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, Addenbrooke's Hospital, Hills Road, CB2 0QQ Cambridge, UK
  More Information

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.

Responsible Party: Mr Peter John Kirkpatrick, Addenbrooke's Hospital Identifier: NCT00905931     History of Changes
Other Study ID Numbers: LASH 3
Study First Received: May 19, 2009
Last Updated: June 10, 2010

Keywords provided by University of Cambridge:
Aneurysmal subarachnoid hemorrhage (aSAH)
Cerebral vasospasm
impaired cerebral autoregulation
transient hyperaemic response test
delayed ischaemic neurological deficits

Additional relevant MeSH terms:
Subarachnoid Hemorrhage
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents processed this record on April 21, 2017