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Lycopene Following Aneurysmal Subarachnoid Haemorrhage (LASH)

Primary Purpose

Subarachnoid Hemorrhage, Aneurysm

Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Lycopene
placebo
Sponsored by
University of Cambridge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Subarachnoid Hemorrhage focused on measuring Aneurysmal subarachnoid hemorrhage (aSAH), Cerebral vasospasm, impaired cerebral autoregulation, transient hyperaemic response test, delayed ischaemic neurological deficits

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Addenbrooke's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Incidence of vasospasm
Mean flow velocity in MCA > 120 cm/min; LR > 3 (4 if age < 50 years old)
Duration of impaired autoregulation measured with transcranial Doppler
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

Full Information

First Posted
May 19, 2009
Last Updated
June 10, 2010
Sponsor
University of Cambridge
Collaborators
Cambridge Theranostics Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00905931
Brief Title
Lycopene Following Aneurysmal Subarachnoid Haemorrhage
Acronym
LASH
Official Title
Acute Oral Lycopene Therapy on Cerebral Autoregulation and Delayed Ischaemic Deficits Following Aneurysmal Subarachnoid Haemorrhage (LASH): A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
October 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Cambridge
Collaborators
Cambridge Theranostics Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage, Aneurysm
Keywords
Aneurysmal subarachnoid hemorrhage (aSAH), Cerebral vasospasm, impaired cerebral autoregulation, transient hyperaemic response test, delayed ischaemic neurological deficits

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lycopene
Intervention Description
30 mg oral, daily, for 21 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
starch
Primary Outcome Measure Information:
Title
Incidence of vasospasm
Description
Mean flow velocity in MCA > 120 cm/min; LR > 3 (4 if age < 50 years old)
Time Frame
Daily for 21 days
Title
Duration of impaired autoregulation measured with transcranial Doppler
Description
Transient hyperaemic response test; Mx
Time Frame
Daily for 21 days
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karol P Budohoski, MD
Phone
(0044)1223331763
Ext
72831763
Email
kpb26@cam.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J Kirkpatrick, FRCS(SN)
Organizational Affiliation
Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, Addenbrooke's Hospital, Hills Road, CB2 0QQ Cambridge, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter J Kirkpatrick, FRCS(SN)
Phone
(0044)1223245151
Email
pjk21@medschl.cam.ac.uk
First Name & Middle Initial & Last Name & Degree
Karol P Budohoski, MD
Phone
(0044)1223 331763
Email
kpb26@cam.ac.uk

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
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Lycopene Following Aneurysmal Subarachnoid Haemorrhage

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