Vasospasms following aneurysmal subarachnoid hemorrhage Circulatory System
Conditions
Interventions
Eligible participants are adult patients 18 years old and older with an aneurysmal subarachnoid hemorrhage confirmed by a brain CT scan, CT angiography, magnetic resonance angiography or digital subtr
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aneurysmal subarachnoid hemorrhage verified by a brain CT scan 2. Older than 18 years old 3. Admitted less than 6 hours after the onset of clinical symptoms 4. World Federation of Neurological Surgeons (WFNS) score I, II and III at admission
Exclusion criteria
Exclusion criteria: 1. Patients who have hypersensitivity to aspirin, ibuprofen or other NSAIDs 2. Previous and prolonged use of any type of NSAIDs other than aspirin 3. History of aneurysmal re-bleeding, and active bleeding of a gastrointestinal ulcer, hemodynamic instability, and pregnancy 4. Patients with a history of myocardial infarction(MI) or percutaneous coronary interventions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcomes (measured using case report forms): 1. Ability to recruit 30 participants over 12 months 2. Ability to follow 85% of participants for 3 months 3. Patient compliance with the study treatment if 75% of participants comply with 75% of the protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcomes for the definitive trial: 1. All-cause mortality until discharge and by the end of follow-up measured using patient records 2. Cerebral vasospasm: defined as detection of vasospasm by either digital subtraction angiography (DSA) or transcranial Doppler (TCD). Angiographic vasospasm is defined as focal or generalized reduction of cerebral arterial caliber on conventional cerebral angiogram. TCD vasospasm is defined as any peak systolic middle cerebral artery velocity (PSVMCA) _120 cm/s and a Lindegaard ratio of >3 and it will be assessed every other day during the hospitalization 3. Delayed cerebral ischemia (DCI): The occurrence of DCI defined as the development of new, focal neurological deficits, and/or a decreased level of consciousness of at least two points on the Glasgow Coma Scale (GCS) after other possible causes of deterioration have been excluded assessed every other day during the hospitalization 4. Disability at discharge and 3 months using Modified Rankin Scale (mRS) at three-month follow-up. Favorable mRS outcomes are (mRS 1 and 2) and unfavorable outcomes are (mRS 3 to 6) | — |
Countries
Iran
Outcome results
None listed