Lycopene Following Aneurysmal Subarachnoid Haemorrhage (LASH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00905931
Recruitment Status : Unknown
Verified June 2010 by University of Cambridge.
Recruitment status was:  Not yet recruiting
First Posted : May 21, 2009
Last Update Posted : June 11, 2010
Cambridge Theranostics Ltd
Information provided by:
University of Cambridge

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.

Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage Aneurysm Drug: Lycopene Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : September 2010
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Lycopene
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Active Drug: Lycopene
30 mg oral, daily, for 21 days
Placebo Comparator: Placebo Drug: placebo

Primary Outcome Measures :
  1. 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)

  2. Duration of impaired autoregulation measured with transcranial Doppler [ Time Frame: Daily for 21 days ]
    Transient hyperaemic response test; Mx

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: May 21, 2009    Key Record Dates
Last Update Posted: June 11, 2010
Last Verified: June 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