Evidence map›Paper›PMID 33143640›Full record

Trial reportBMC neurology2020

Randomized, placebo-controlled, double-blind, pilot trial to investigate safety and efficacy of Cerebrolysin in patients with aneurysmal subarachnoid hemorrhage.

Peter Y M Woo, Joanna W K Ho, Natalie M W Ko, Ronald P T Li, Leo Jian, Alberto C H Chu, Marco C L Kwan, Yung Chan, Alain K S Wong, Hoi-Tung Wong and 2 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in BMC neurology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01787123 (Randomized, Double-blind, Placebo-controlled Pilot Trial to Investigate Safety and Efficacy of Cerebrolysin™ in Patients With Aneurysmal Subarachnoid Hemorrhage), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01787123 phase2 / phase3completednot on this map

Randomized, Double-blind, Placebo-controlled Pilot Trial to Investigate Safety and Efficacy of Cerebrolysin™ in Patients With Aneurysmal Subarachnoid Hemorrhage

TypeinterventionalSponsorKwong Wah HospitalRan2013 to 2019Enrolled50ConditionsSubarachnoid Hemorrhage, Intracranial Aneurysm, Delayed Cerebral Ischemia, Delayed Ischemic Neurological DeficitArmsIntravenous Cerebrolysin, Normal Saline
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Outcomes Measures in Subarachnoid Hemorrhage Research.Translational stroke research · 2025
    Review
  4. Article
  5. Article
  6. Pharmacotherapy in SAH: Clinical Trial Lessons.CNS & neurological disorders drug targets · 2024
    Review
  7. Review
  8. Review
  9. Article
  10. Article
  11. Article
  12. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Peter Y M WooDepartment of Neurosurgery, Kwong Wah Hospital, Room CS11-01, 11th Floor, 25 Waterloo Road, Yaumatei, Hong Kong, China. wym307@ha.org.hk.ORCID http://orcid.org/0000-0002-7345-7904
Joanna W K HoDepartment of Neurosurgery, Kwong Wah Hospital, Room CS11-01, 11th Floor, 25 Waterloo Road, Yaumatei, Hong Kong, China.
Natalie M W KoDepartment of Neurosurgery, Kwong Wah Hospital, Room CS11-01, 11th Floor, 25 Waterloo Road, Yaumatei, Hong Kong, China.
Ronald P T LiDepartment of Neurosurgery, Kwong Wah Hospital, Room CS11-01, 11th Floor, 25 Waterloo Road, Yaumatei, Hong Kong, China.
Leo JianDepartment of Neurosurgery, Kwong Wah Hospital, Room CS11-01, 11th Floor, 25 Waterloo Road, Yaumatei, Hong Kong, China.
Alberto C H ChuDepartment of Neurosurgery, Kwong Wah Hospital, Room CS11-01, 11th Floor, 25 Waterloo Road, Yaumatei, Hong Kong, China.
Marco C L KwanDepartment of Neurosurgery, Kwong Wah Hospital, Room CS11-01, 11th Floor, 25 Waterloo Road, Yaumatei, Hong Kong, China.
Yung ChanDepartment of Neurosurgery, Kwong Wah Hospital, Room CS11-01, 11th Floor, 25 Waterloo Road, Yaumatei, Hong Kong, China.
Alain K S WongDepartment of Neurosurgery, Kwong Wah Hospital, Room CS11-01, 11th Floor, 25 Waterloo Road, Yaumatei, Hong Kong, China.
Hoi-Tung WongDepartment of Neurosurgery, Kwong Wah Hospital, Room CS11-01, 11th Floor, 25 Waterloo Road, Yaumatei, Hong Kong, China.
Kwong-Yau ChanDepartment of Neurosurgery, Kwong Wah Hospital, Room CS11-01, 11th Floor, 25 Waterloo Road, Yaumatei, Hong Kong, China.
John C K KwokDepartment of Neurosurgery, Kwong Wah Hospital, Room CS11-01, 11th Floor, 25 Waterloo Road, Yaumatei, Hong Kong, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

asbtract

backgroundThere are limited neuroprotective treatment options for patients with aneurysmal subarachnoid hemorrhage (SAH). Cerebrolysin, a brain-specific proposed pleiotropic neuroprotective agent, has been suggested to improve global functional outcomes in ischemic stroke. We investigated the efficacy, safety and feasibility of administering Cerebrolysin for SAH patients.

methodsThis was a prospective, randomized, double-blind, placebo-controlled, single-center, parallel-group pilot study. Fifty patients received either daily Cerebrolysin (30 ml/day) or a placebo (saline) for 14 days (25 patients per study group). The primary endpoint was a favorable Extended Glasgow Outcome Scale (GOSE) of 5 to 8 (moderate disability to good recovery) at six-months. Secondary endpoints included the modified Ranking Scale (mRS), the Montreal Cognitive Assessment (MOCA) score, occurrence of adverse effects and the occurrence of delayed cerebral ischemia (DCI).

resultsNo severe adverse effects or mortality attributable to Cerebrolysin were observed. No significant difference was detected in the proportion of patients with favorable six-month GOSE in either study group (odds ratio (OR): 1.49; 95% confidence interval (CI): 0.43-5.17). Secondary functional outcome measures for favorable six-month recovery i.e. a mRS of 0 to 3 (OR: 3.45; 95% CI 0.79-15.01) were comparable for both groups. Similarly, there was no difference in MOCA neurocognitive performance (p-value: 0.75) and in the incidence of DCI (OR: 0.85 95% CI: 0.28-2.59).

conclusionsUse of Cerebrolysin in addition to standard-of-care management of aneurysmal SAH is safe, well tolerated and feasible. However, the neutral results of this trial suggest that it does not improve the six-month global functional performance of patients. CLINICAL

trial registrationName of Registry: ClinicalTrials.gov Trial Registration Number: NCT01787123 . Date of Registration: 8th February 2013.

Indexed as

AdultAgedAmino AcidsBrain IschemiaDouble-Blind MethodFemaleGlasgow Outcome ScaleHumansMaleMiddle AgedNeuroprotective AgentsPilot ProjectsProspective StudiesSubarachnoid HemorrhageTreatment OutcomeAmino AcidscerebrolysinNeuroprotective AgentsAneurysmal subarachnoid hemorrhageDelayed cerebral ischemiaNeuroprotection

Identifiers

PMID33143640
PMCPMC7607674

What Socratic holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.