Subarachnoid HemorrhagePhase 2LASHNCT00905931
Lycopene Following Aneurysmal Subarachnoid Haemorrhage
A Phase 2 study testing Lycopene in people with Subarachnoid Hemorrhage and Aneurysm, run by University of Cambridge at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysm
- What is being tested?
- Lycopene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2010to Oct 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: > 18 years old,
- Confirmed aneurysmal subarachnoid hemorrhage (aSAH),
- Time from ictus < 96 hours
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 0QQ
Peter J Kirkpatrick, FRCS(SN), (0044)1223245151, pjk21@medschl.cam.ac.uk
Karol P Budohoski, MD, (0044)1223 331763, kpb26@cam.ac.uk
About this study
Official title: Acute Oral Lycopene Therapy on Cerebral Autoregulation and Delayed Ischaemic Deficits Following Aneurysmal Subarachnoid Haemorrhage (LASH): A Randomized Controlled Trial
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.
- Conditions
- Subarachnoid Hemorrhage, Aneurysm
- Being tested
- Lycopene, placebo
- Keywords
- Aneurysmal subarachnoid hemorrhage (aSAH), Cerebral vasospasm, impaired cerebral autoregulation, transient hyperaemic response test, delayed ischaemic neurological deficits
- Medical subject headings
- Subarachnoid Hemorrhage, Aneurysm, Vasospasm, Intracranial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LycopeneDrug
30 mg oral, daily, for 21 days
placeboDrug
starch
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Not described Receives: Drug: Lycopene |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of vasospasm
Mean flow velocity in MCA > 120 cm/min; LR > 3 (4 if age < 50 years old)
Measured: Daily for 21 days
Duration of impaired autoregulation measured with transcranial Doppler
Transient hyperaemic response test; Mx
Measured: Daily for 21 days
Secondary outcomes (1)
Level of biochemical markers of vascular injury: LDL, oxy-LDL, CRP, circulating endothelial cells, endothelial progenitor cells
Measured: Days: 0, 3, 6, 12, 14, 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startSep 2010
- Primary completionJun 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge Theranostics Ltd
- Investigators
- Peter J Kirkpatrick, FRCS(SN), Principal investigator, Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, Addenbrooke's Hospital, Hills Road, CB2 0QQ Cambridge, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905931
- Sponsor's protocol ID
- LASH 3
- Acronym
- LASH
- Status last verified
- Jun 2010
- First submitted
- 19 May 2009
- Last updated
- 11 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Oral Lycopene Therapy on Cerebral Autoregulation and Delayed Ischaemic Deficits Following Aneurysmal Subarachnoid Haemorrhage (LASH): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00905931
- Acronym / sponsor ID
- LASH / LASH 3
- Conditions
- Subarachnoid Hemorrhage, Aneurysm
- Keywords
- Aneurysmal subarachnoid hemorrhage (aSAH), Cerebral vasospasm, impaired cerebral autoregulation, transient hyperaemic response test, delayed ischaemic neurological deficits
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Cambridge Theranostics Ltd
- Study start
- Sep 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 21 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: Lycopene |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: > 18 years old,
- Confirmed aneurysmal subarachnoid hemorrhage (aSAH),
- Time from ictus < 96 hours
Key exclusion criteria (6 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lycopene30 mg oral, daily, for 21 days | Drug | Active |
| placebostarch | Drug | Placebo |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2010.
- BackgroundVerghese 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.
Related trials for Subarachnoid Hemorrhage
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
Not yet recruitingPhase 1/2
Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
Aneurysmal Subarachnoid Hemorrhage
RecruitingPhase 2
Infusion of Lidocaine and Steroids in Middle Meningeal Artery for Pain in Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Headache
Not yet recruiting
Endovascular Therapy for Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Cerebral Vasospasm After Subarachnoid Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter J Kirkpatrick, FRCS(SN) principal investigator
Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, Addenbrooke's Hospital, Hills Road, CB2 0QQ Cambridge, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lycopene in people with Subarachnoid Hemorrhage and Aneurysm, run by University of Cambridge at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karol P Budohoski, MD ((0044)1223331763 ext. 72831763, kpb26@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of vasospasm (time frame: Daily for 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00905931, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2010.