Haemorrhagic stroke can lead to complex neurological sequelae despite aggressive secondary brain injury prevention. Cerebrolysin is a neuroprotective agent composed of peptides extracted from pig brain that may help promote motor function recovery. The objective of this study was to compare the efficacy and safety of cerebrolysin with those of usual care in improving of haemorrhagic stroke patients in a minimally conscious state (MCS).This randomized, single-blinded study, conducted from Decembe
Conditions
Interventions
A randomized interventional prospective cohort study was conducted from December 2016 to February 2024. Sixty-eight subjects, including all adult patients with haemorrhagic stroke who met the criteria
Cerebrolysin protocol,usual care
Sponsors
Phramongkutklao hospital foundation
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. All the adult patients with haemorrhagic stroke in a minimally conscious state 2. Age more than 20 years 3. Patients have focal neurological deficits presenting with magnetic resonance imaging (MRI) brain or computed tomography (CT) head suggestive of haemorrhagic stroke in a minimally conscious state within 24 hour of symptom onset.
Exclusion criteria
Exclusion criteria: 1. patients with a preexisting or active major neurological disease/condition such as traumatic brain injury, brain tumour-related epilepsy, previous intracerebral haemorrhage and ischaemic stroke, or neurodegenerative disease 2. patients with a diagnosis of brain lesions other than haemorrhagic stroke, such as traumatic brain injury (epidural or subdural haematoma) or hypoxic ischaemic encephalopathy 3. patients with progressive haemorrhagic stroke, haematoma expansion, or unstable haemodynamics 4. patients with a history of significant alcohol abuse or drug intoxication and advanced liver, kidney, cardiac, or pulmonary disease (abnormal values of liver enzymes: total bilirubin more than 4 mg/dl, alkaline phosphatase more than 250 U/L, SGOT more than 150 U/L, SGPT more than 150 U/L, and creatinine more than 3.5 mg/dl) 5. patients with a medical diagnosis of an expected survival less than 1 year 6. patients with active carcinoma of any origin; patients currently under treatment with traditional medications (e.g., vasodilators such as cinnarizine, flunarizine, or nimodipine) 7. patients with any condition that was a contraindication for cerebrolysin use or previous history of cerebrolysin treatment 8. patients who participated in other alternative neurotrophic therapy or therapeutic studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neurological outcome 6 months modified ranking score at 6 months,Neurological outcome 6 months the Coma Recovery Scale-Revised score | — |
Secondary
| Measure | Time frame |
|---|---|
| disability improve ment 6 months NIHSS and BI scores at 6 months,Functional improvement 6 months mRS and BI scores at 6 months | — |
Countries
Thailand
Contacts
Public ContactPANU BOONTOTERM
Phramongkutklao College of Medicine and Hospital
Outcome results
None listed