Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202306562134107 Date of Approval: 27/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of Cerebrolysin as an Adjuvant Therapy Following Mechanical Thrombectomy in Patients with Large Vessel Occlusion Stroke: A retrospective study
Official scientific title Efficacy of Cerebrolysin as an Adjuvant Therapy Following Mechanical Thrombectomy in Patients with Large Vessel Occlusion Stroke: A retrospective study
Brief summary describing the background and objectives of the trial Neuroprotective agents have been investigated as an adjuvant to conventional recanalization therapies for patients who are not eligible for thrombolysis or- and thrombectomy with limited evidence and success. Cerebrolysin, a preparation of low molecular weight neuropeptides and free amino acids has shown neuro-protective and neuro-tropic effects in vivo and in vitro with promising data in improving motor function in acute ischemic stroke patients . Our objective of the trial is to assess the efficacy of cerebrolysin treatment as an add-on therapy to mechanical thrombectomy in reducing the global disability in patients with acute ischemic stroke due to large vessel occlusion.
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 22/04/2024
Actual trial start date 22/04/2024
Anticipated date of last follow up 22/04/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group IV cerebrolysin 30 ml of IV cerebrolysin diluted with 100 ml of 0.9% normal saline. It will be given immediately after thrombectomy in the first 8 hours for 14 days. Once daily for 14 days standard therapy which is IV thrombolysis and mechnical thrombectomy followed immediately by 30 ml of IV cerebrolysin diluted with 100 ml of 0.9% normal saline. It will be given immediately after thrombectomy in the first 8 hours for 14 days. 25
Control Group Standard therapy only which is IV thrombolysis plus mechanical thrombectomy no cerebrolysin is given no intervention 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Patients with acute cardioembolic stroke as defined by TOAST classification. - Evidence of large vessel occlusion - NIHSS ≥10, - Underwent successful mechanical thrombectomy ± IV thrombolysis, after fulfilling the standard eligibility criteria. - Patients aged more than 80 years old - Patients with epilepsy - Patients who are pregnant or lactating - Patients serious, advanced, or terminal illness or life expectancy ≤ 6 months - Patients with bleeding tendency or platelet count less than 100,000/uL - Patients with high INR above 1.7 - Patient receiving low molecular weight heparin therapy less than 24 hours of stroke onset. - Patient with premorbid cognitive impairment Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 79 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/04/2024 Research Ethics committee at the Faculty of medicine Ain Shams University
Ethics Committee Address
Street address City Postal code Country
38 Abbassia, Next to the Al-Nour Mosque. Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The Primary outcome measure will be the overall proportion of subjects receiving Cerebrolysin compared to the control group experiencing a favorable functional outcome (by modified Rankin Scale0–2 and MOCA score) at 90 days, following stroke onset. At 90 days
Secondary Outcome The Secondary outcomes are to determine the efficacy of Cerebrolysin as compared to the control group in reducing the risk of symptomatic secondary hemorrhagic transformation, improving neurological outcomes(NIHSS 0–2 at day 14, day 30, and 90), reducing mortality rates (over the 90-day). At day 14, day 30 and 90
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University hospitals 38 Abbassia, Next to the Al-Nour Mosque. Cairo 1181 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
hospital and principle investigator 38 Abbassia, Next to the Al-Nour Mosque Cairo 1181 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University hospital 38 Abbassia, Next to the Al-Nour Mosque. Cairo 1181 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ahmed Ali Ibrahim ElBassiouny 38 Abbassia, Next to the Al-Nour Mosque. Cairo 1181 Egypt
Azza Abdel Naser Abdel Aziz 38 Abbassia, Next to the Al-Nour Mosque. Cairo 1181 Egypt
Ayman Hassan Othman El Sudany 38 Abbassia, Next to the Al-Nour Mosque. Cairo 1181 Egypt
Rady Yousif Bedros Kaldas 38 Abbassia, Next to the Al-Nour Mosque Cairo 1181 Egypt
Mohamed Shehata Ahmed Shehata 38 Abbassia, Next to the Al-Nour Mosque Cairo 1181 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Azza Abd ElNaser drazzasaeed@yahoo.com +201001240246 38 Abbassia, Next to the Al-Nour Mosque
City Postal code Country Position/Affiliation
Cairo 1181 Egypt Professor of Neurology Ain Shams University
Role Name Email Phone Street address
Public Enquiries Ayman El Sudany aymanhsudany@gmail.com +201110805581 38 Abbassia, Next to the Al-Nour Mosque
City Postal code Country Position/Affiliation
Cairo 1181 Egypt Lecturer of neurology Ain Shams university
Role Name Email Phone Street address
Scientific Enquiries Ahmed ElBassiouny ahmedelbassiony@gmail.com +201222132125 38 Abbassia, Next to the Al-Nour Mosque
City Postal code Country Position/Affiliation
Cairo 1181 Egypt Professor of neurology Ain Shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will make de-identified individual participate data collected in this study, including data dictionaries, available to other researchers after the end of the study Informed Consent Form,Statistical Analysis Plan,Study Protocol 6 months All research documents will be available for monitoring done by a monitoring board described by FMASU REC
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information