Clinical trial to evaluate the Efficacy and safety of NIMODIN IV infusion 50 ml with Nimotop IV infusion 50 ml for the treatment of intra-cerebral hemorrhage
- Conditions
- Health Condition 1: G939- Disorder of brain, unspecified
- Registration Number
- CTRI/2020/06/025822
- Lead Sponsor
- Swiss Parenterals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢To reduce and maintain the SBP between 120 and 140 mmhg.Timepoint: 3 hr, 6 hr, 8 hr, 12 hr and 24 hr after initiation of infusion
- Secondary Outcome Measures
Name Time Method 1.To evaluate the changes of Neurological status by GCS scale. <br/ ><br>2.To evaluate ICH values (Incidence of Hematoma expansion/volume) by CTA (Computed tomography angiography) <br/ ><br>3.To evaluate and recording the Hemodynamic indics (SBP, HR, ICP) at baseline and 24 hours monitoring after initiation of infusion) <br/ ><br>4.Incidence of Adverse events and Serious Adverse Events throughout the trial duration <br/ ><br>Timepoint: Baseline to EOT