Aneurysmal Subarachnoid Hemorrhage
Conditions
Keywords
Delayed cerebral ischemia, Cerebral vasospasm, Cilostazol
Brief summary
The investigators seek to demonstrate that the combined use of cilostazol and nimodipine will significantly decrease the rate of delayed cerebral infarction and cerebral vasospasm after cerebrovascular intervention when compared to nimodipine alone.
Detailed description
This research study is for people who have a brain hemorrhage, due to a ruptured aneurysm. Adding the drug cilostazol to the standard care may improve outcomes after surgery. The blood within the brain following aneurysmal hemorrhage can have harmful effects on the blood vessels causing them to narrow and thus decrease blood flow; this process is called vasospasm. Decreased blood flow in the brain can lead to more damage. Delayed cerebral ischemia is a complication which is believed to be a consequence of reduced blood flow to the brain following this type of hemorrhage. Cilostazol opens blood vessels and reduces the formation of blood clots. The standard treatment of these hemorrhages currently involves the use of nimodipine which also relaxes blood vessels and allows blood to flow more freely. The combination of these two drugs cilostazol and nimodipine may improve neurologic outcomes after surgery.
Interventions
The addition of 100 mg cilostazol, twice daily for 14 days, to the standard treatment regimen of 60 mg nimodipine every 4 hours for 21 days and the standard aneurysmal subarachnoid treatment pathway
OTHERPlacebo
The standard treatment regimen of 60 mg nimodipine every 4 hours for 21 days and the standard aneurysmal subarachnoid treatment pathway
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Anterior circulation aneurysm * Patients who have undergone surgical intervention * Absence of rebleeding or new intracranial hemorrhage noted on post-intervention CT scan * Consent for study participation
Exclusion criteria
* Non-aneurysmal subarachnoid hemorrhage * Multiple ruptured aneurysms * Patients with congestive heart failure * Severe aneurysmal subarachnoid hemorrhage (Hunt Hess Grade V) * Active pathological bleeding * Allergy to cilostazol * Positive pregnancy test * Coagulopathy not caused by anti-coagulant use * History of hemorrhagic complications (gastrointestinal bleeding, etc) * Uncontrolled or severe comorbidity that would qualify as an absolute contraindication for cilostazol * Patients requiring anticoagulant/antiplatelet treatment following intervention (e.g. stent-assisted coiling or flow-diverting stent obliteration of aneurysm)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delayed Cerebral Infarction | Baseline | Ischemic lesions demonstrated on follow-up CT or MRI will be interpreted as new cerebral infarctions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic Cerebral Vasospasm | At any point leading up to 14 days post-operation | Development of a new focal or global neurological deficit or deterioration of at least 2 points on the Glasgow Coma Scale which was not explained by initial hemorrhage, re-bleeding, hydrocephalus, surgical complications, fever, infections, or electrolyte or metabolic disturbances; regardless of cerebral infarctions or angiographic vasospasm on imaging |
| Radiographic Vasospasm | Between 7-10 days postoperatively | Arterial narrowing not attributable to atherosclerosis, catheter-induced vasospasm, or vessel hypoplasia |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Outcomes: Short-Form 12 | Baseline, 1 month postoperatively, 3 month postoperatively, and 6 month postoperatively | Short-Form 12 is answered by the patient. On a scale of 0-100, a higher score means better overall physical and mental health. |
| Modified Rankin Scale | Baseline, 1 month postoperatively, 3 month postoperatively, 6 month postoperatively | The patient's clinical status is graded on a scale of 0-6. An increasing score means a worse functional outcome. |
Countries
United States
Outcome results
None listed