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Lycopene Following Aneurysmal Subarachnoid Haemorrhage (LASH)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Cambridge.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Cambridge Theranostics Ltd
Information provided by:
University of Cambridge
ClinicalTrials.gov Identifier:
NCT00905931
First received: May 19, 2009
Last updated: June 10, 2010
Last verified: June 2010
  Purpose

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
Aneurysm
Drug: Lycopene
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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
starch

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905931

Contacts
Contact: Karol P Budohoski, MD (0044)1223331763 ext 72831763 kpb26@cam.ac.uk

Locations
United Kingdom
Addenbrooke's Hospital Not yet recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Contact: Peter J Kirkpatrick, FRCS(SN)    (0044)1223245151    pjk21@medschl.cam.ac.uk   
Contact: Karol P Budohoski, MD    (0044)1223 331763    kpb26@cam.ac.uk   
Sponsors and Collaborators
University of Cambridge
Cambridge Theranostics Ltd
Investigators
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

No publications provided

Responsible Party: Mr Peter John Kirkpatrick, Addenbrooke's Hospital
ClinicalTrials.gov Identifier: NCT00905931     History of Changes
Other Study ID Numbers: LASH 3
Study First Received: May 19, 2009
Last Updated: June 10, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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:
Hemorrhage
Subarachnoid Hemorrhage
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Vascular Diseases
Lycopene
Anticarcinogenic Agents
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Radiation-Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014