What is the use and dosage of Cerebrolysin (neurotrophic peptide) in treating acute ischemic stroke or traumatic brain injury?

Cerebrolysin for Acute Ischemic Stroke and Traumatic Brain Injury

Cerebrolysin is NOT recommended for routine use in acute ischemic stroke based on the highest quality evidence showing no mortality benefit and a potential increase in non-fatal serious adverse events. 1

Evidence Quality and Recommendations

Acute Ischemic Stroke

The most recent high-quality Cochrane systematic review (2020) demonstrates that Cerebrolysin probably results in little to no difference in all-cause death (RR 0.90,95% CI 0.61 to 1.32) and may increase non-fatal serious adverse events (RR 2.15,95% CI 1.01 to 4.55). 1 This evidence directly contradicts any recommendation for routine use when prioritizing morbidity and mortality outcomes.

Key Safety Concerns:

• The 30 mL daily dose for 10 days (cumulative 300 mL) showed the most concerning safety profile, with RR 2.86 (95% CI 1.23 to 6.66) for non-fatal serious adverse events. 1
• Four of seven trials in the Cochrane review were manufacturer-supported, introducing potential bias. 1
• The evidence quality was downgraded due to unclear or high risk of bias across multiple domains. 1

Guideline Context:

American Heart Association guidelines (2013) mention Cerebrolysin only briefly, noting it "was safe and might improve outcomes" in a small study, but this falls far short of a recommendation. 2 No major stroke guidelines recommend Cerebrolysin as standard therapy. 3

In contrast, proven therapies for acute ischemic stroke include:

• IV rtPA 0.9 mg/kg (maximum 90 mg) within 3 hours produces a 12% absolute increase in minimal or no disability (NNT ≈ 8). 3
• Aspirin 160-325 mg within 48 hours (but NOT within 24 hours of rtPA) is recommended as Grade 1A evidence. 3

Traumatic Brain Injury

For traumatic brain injury, the evidence is even weaker, consisting only of a single 2005 cohort study showing potential benefit in moderate-to-severe head injury. 4 This study reported 67% good outcome (GOS 3-5) at 6 months with Cerebrolysin versus historical controls (p=0.065, not statistically significant). 4

Critical Limitations:

• Non-randomized historical control design (very low quality evidence)
• No current guideline support from major trauma or neurocritical care societies
• Insufficient evidence to recommend for mortality or morbidity reduction

Dosing Information (For Reference Only)

If Cerebrolysin were to be used (which is NOT recommended based on current evidence), the studied regimens were:

• 30-50 mL daily via IV infusion for 10-21 days, initiated within 48-72 hours of symptom onset. 1, 5
• The 30 mL for 10 days regimen showed the highest rate of adverse events. 1

Clinical Bottom Line

Prioritizing morbidity, mortality, and quality of life outcomes, Cerebrolysin should NOT be used in acute ischemic stroke or traumatic brain injury outside of research protocols. The 2020 Cochrane review—the highest quality and most recent evidence—shows no mortality benefit and potential harm. 1

Instead, focus on proven therapies:

• For acute ischemic stroke: IV rtPA within 3 hours (or 3-4.5 hours with ECASS III criteria) and aspirin within 48 hours. 3
• For traumatic brain injury: Standard neurocritical care protocols with blood pressure management (SBP >110 mmHg, MAP >90 mmHg) and avoidance of hypoxia. 2

Common pitfall: Being swayed by older, smaller studies or meta-analyses that show surrogate outcomes (like NIHSS improvement) rather than patient-centered outcomes (mortality, functional independence). 5 The Cochrane review's focus on mortality and serious adverse events provides the most clinically relevant evidence. 1