Evaluation of the Safety and Efficacy of Parecoxib in Patients With Subarachnoid Hemorrhage

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorSt. Anne's University Hospital Brno, Czech Republic

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Parecoxib
  • Placebo

Treatment groups

112 Participants
are divided into 2 treatment groups

Sponsors and collaborators

St. Anne's University Hospital Brno, Czech Republic

Lead sponsor

Masaryk University

Collaborator

CZECRIN - Czech Clinical Research Infrastructure Network

Collaborator