Lumbar Drainage in Subarachnoid Haemorrhage (NCT00842049) | Clinical Trial Compass
CompletedPhase 2
Lumbar Drainage in Subarachnoid Haemorrhage
United Kingdom210 participantsStarted 2006-11
Plain-language summary
Subarachnoid haemorrhage affects approximately 8000 people per year in the UK. The average age of a patient with subarachnoid haemorrhage is 50 years, although it is often seen in younger people (25-45 years). Despite modern medicine, the death and disability rate remains high both from the initial bleed and from the associated complications such as vasospasm. This is characterised by neurological impairment seen following the bleed. Despite modern treatment this is still associated with a poor outcome. This has significant implications due to the long term intensive neuro-rehabilitation these patients will require.
A recent study has shown that placing a small drain in the lower back following a subarachnoid haemorrhage may reduce the chance of vasospasm occurring and result in a better outcome. This trial was not optimally performed and so a trial is needed to look at this in more detail. The investigators have set up such a trial in our neurosurgical unit. If the investigators confirm that there is an improvement in patient outcome, it will change our practice in the future.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
β. Aneurysmal subarachnoid haemorrhage.
β. Recruitment prior to day three post-haemorrhage.
β. Written informed consent or relative assent given.
β. WFNS grade 1-3.
β. Fisher grade 2, 3 and 4 (without space occupying haematoma) on initial CT scan.
β. No intraventricular haemorrhage, space occupying haematoma or other contra-indication to lumbar puncture.
Exclusion criteria
β. Non-aneurysmal subarachnoid haemorrhage.
β. Delayed presentation / recruitment (after day three post-haemorrhage)
β. Written informed consent or relative assent denied or unobtainable.
β. WFNS grade 4 or 5.
β. Fisher grade 1 on initial CT scan.
What they're measuring
1
Incidence of delayed ischaemic neurological deficit