Because of the important role of inflammation in the pathophysiology of SAH, it was hypothesized that its pharmacological manipulation might improve the prognosis of patients. In recent years, the effects of several groups of anti-inflammatory drugs on the development of complications after SAH have been described. Initially promising, glucocorticoids, thought to reduce cerebrovascular inflammation, brain swelling, and headache, failed in clinical trials. Studies have not provided clear evidence of the beneficial effects of these drugs in patients after SAH. Therefore, the administration of glucocorticoids is not currently part of the recommended practice. In addition, glucocorticoid treatment is associated with adverse effects that worsen outcomes, including hyperglycemia, infection, and the risk of gastrointestinal bleeding.
Signed informed consent
Age: 18-85 years
Weight> 50 kg
Spontaneous SAH diagnosed on a native CT brain max. 48 hours after the first symptoms
Symptoms of SAH without the finding of blood on the initial native CT scan of the brain
SAH from a cause other than a ruptured aneurysm, e.g. A-V malformation, traumatic SAH
Pregnancy and breastfeeding (pregnancy test)
Known hypersensitivity to the components of the product
Parallel
Parecoxib
DrugParecoxib (Dynastat) 40 mg solution for injection is for intravenous administration. Parecoxib may be given as an intravenous injection for 30 minutes directly into a vein or through an intravenous infusion set.
Placebo
DrugPlacebo intravenous injection can be administered quickly and directly into a vein or through an intravenous infusion set.
Influence of parecoxib on outcome of patients with SAH
The primary outcome measure is the percentage of patients in the active and control groups whose outcome is categorized as favorable (mRS 0-3) or unfavorable (mRS 4-6) according to the modified Rankin Scale (mRS).
Influence of parecoxib on outcome of patients with SAH
The secondary monitored parameter is the percentage of patients in the active and control groups whose outcome, according to the modified Rankin scale (mRS), is divided into favourable (mRS 0-3) or unfavourable (mRS 4-6).
Occurrence of symptomatic vasospasms (vasospasms confirmed on TCD / CT AG / MR AG / DSA
Number of patients with vasospasms confirmed on TCD / CT AG / MR AG / DSA
Incidence of delayed ischemic neurological deficit (DIND)
Number of patients with delayed ischemic neurological deficit
Mortality
Number of deaths
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St. Anne's University Hospital Brno, Czech Republic
Lead sponsor
Masaryk University
Collaborator
CZECRIN - Czech Clinical Research Infrastructure Network
Collaborator
