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
Recruitment status was Not yet recruiting
Sponsor:
University of Cambridge
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
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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
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:
|
Aneurysm Hemorrhage Subarachnoid Hemorrhage Vascular Diseases Cardiovascular Diseases Pathologic Processes Intracranial Hemorrhages Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Lycopene Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Radiation-Protective Agents Anticarcinogenic Agents Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013