Health Condition 1: null- Non-traumatic subarachnoid hemorrhage
Conditions
Interventions
Intervention1: Fasudil hydrochloride injection 30 mg/2 ml: 1 ampoule to be dissolved in 100 ml normal saline administered as intravenous slow infusion (over 30 minutes) every 8 hourly for 14 days
Co
Patients of body weight less than 70 kg or with unstable blood pressure should be started 7.5 microgram/kg bw/h
co-infusion with intravenous fluids 40 ml/hour
Sponsors
Intas Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1)Either sex, age between 18 and 70 years hospitalized with non-traumatic SAH (subarachnoid hemorrhage) 2)In case of females with child bearing potential, negative serum pregnancy test at screening and willing to use medically acceptable contraceptive through out the study period 3)Himself/herself or his/her legally accepted representative willing to provide written informed consent 4)For whom study medication can be started within 56 hours of detection of SAH
Exclusion criteria
Exclusion criteria: 1)Recent history of stroke or subarachnoid hemorrhage 2)Patients with hypotension (systolic blood pressure (SBP) < or = 90 mm Hg) at baseline 3)Patient with serious disturbance of consciousness, patient with subarachnoid hemorrhage combined with serious cerebrovascular damage 4)Patients with presence of cerebral edema and severely raised intracranial pressure at screening 5)Ongoing lactation 6)Patients with pulmonary edema or severe cardiac failure requiring inotropic support at the time of randomization 7)Hepatic function impairment (SGPT or SGOT level > or = 2.5 times upper normal limit) or renal function impairment (serum creatinine > or = 1.5 times upper normal limit) 8)Ongoing use of prohibited medications ? vasodilators, nephrotoxic drugs, inhibitors of CYP 3A4, intravenous beta blockers 9)As deemed inappropriate for enrollment by investigating physician due to other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Delayed Ischemic Neurological DeficitsTimepoint: During two weeks of treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Neurological worsening 2) Requirement of administration of a valid rescue therapy 3) 3 or score of Modified Rankin Scale Timepoint: 1) During two weeks of treatment period 2) During two weeks of treatment period 3) At the end of study | — |
Countries
India
Contacts
Public ContactDr Dimple Shah
Intas Pharma
Outcome results
None listed