A Prospective, Interventional, Randomized, Double blind, multi-centric, comparative Clinical trial to evaluate the Efficacy and safety of NIMODIN IV infusion (Nimodipine) BP 50 ml with Nimotop IV infusion (Nimodipine) 50 ml for the treatment of hypertension in patients with intra-cerebral hemorrhage.

Swiss Parenterals Ltd0 个研究点目标入组 80 人开始时间: 待定最近更新: 2023年3月6日

试验速览

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•1.Male and Female of Age: Between 18-75 years.
•2.SAH (subarachnoid hemorrhage) which is diagnosed by the physician. (CTA and CT-SCAN)
•3.Patients whose elevated SBP (Systolic blood pressure) at admission reached >140 mmHg.
•4.The total GCS (Glasgow Coma Scale) score of 10 to 15 at time of enrollment.
•5.CT scan demonstrated intraparenchymal hematoma with manual hematoma volume measurement ,60 mL
•6.Willing to give informed consent, if patient is not in the state to give informed consent then either patients or legal representative will be responsible to give informed consent.

•1.During the admission SBP >240 mmHg.
•2.Intraventricular or infratentorial hemorrhage.
•3.Clinical and radiological signs of brain herniation
•4.TBI and aSAH (aneurysmal subarachnoid hemorrhage)
•5.Patients with coagulopathy.
•6.Uncontrollable irritability, pain, or other factors that affect BP.
•7.Any history of congestive heart failure, renal failure, or liver damage.
•8.Known sensitivity to nicardipine or nimodipine.
•9.Currently participating in another investigational study or has participated in an investigational study within 30 days prior to randomization.
•10.Has any other serious disease or condition that would compromise subject safety or make it difficult to successfully manage and follow the subject according to the protocol.
•11.Pregnant and Breast feeding mother.

发起方

Swiss Parenterals Ltd