Ischemic Postconditioning in Carotid Surgery
BRAIN-SAVE
Ischemic Postconditioning in Prevention of Brain Damage After Carotid Surgery - a Clinical Trial for Vascular Evaluation
1 other identifier
interventional
40
1 country
1
Brief Summary
Analyzing changes in cerebral oximetry, transcranial Doppler and biomarkers of neuronal ischemic injury and blood-brain barrier integrity assessing the safety and efficacy of ischemic postconditioning in carotid surgery (IPCT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2023
CompletedFirst Submitted
Initial submission to the registry
April 6, 2024
CompletedFirst Posted
Study publicly available on registry
April 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedMarch 27, 2026
March 1, 2026
2.3 years
April 6, 2024
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants with perioperative stroke
During and 30 days after surgery
Number of Participants with perioperative death
During and 30 days after surgery
Study Arms (2)
Ischemic postconditioning group
EXPERIMENTALPatients with ischemic postconditioning (IPCT) performed after standard eversion carotid endarterectomy (eCEA)
Control
ACTIVE COMPARATORPatients with standard eversion carotid endarterectomy (eCEA) performed with no ischemic postconditioning (IPCT)
Interventions
After the initial declamping of the carotid artery the procedure is performed with 6 cycles of reperfusion of 30 seconds each (clamping of the internal carotid artery) which are successively followed by 6 cycles of ischemia lasting 30 seconds (clamping of the internal carotid artery). Clamping is done on the unaltered ICA, at the clamping site prior to performing CEA above the plaque termination point.
Standard Eversion Carotid Endarterectomy
Eligibility Criteria
You may qualify if:
- unilateral carotid artery stenosis \>90%
- bilateral stenosis \>80%
- unilateral stenosis \>80% with contralateral occlusion/subocclusion
You may not qualify if:
- urgent carotid endarterectomy
- carotid restenosis
- "major surgery" in the last 6 months
- malignant diseases
- previous brain trauma or surgery
- epilepsy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute for Cardiovascular Diseases Dedinje
Belgrade, 11000, Serbia
Related Publications (1)
Ilijevski N, Atanasijevic I, Lozuk B, Gajin P, Matic P, Babic S, Sagic D, Unic-Stojanovic D, Tanaskovic S. Direct Ischemic Postconditioning After Carotid Endarterectomy in the Prevention of Postoperative Cerebral Ischemic Complications-Observational Case-Control Study. J Cardiovasc Pharmacol Ther. 2022 Jan-Dec;27:10742484221137489. doi: 10.1177/10742484221137489.
PMID: 36377766BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nenad Ilijevski, PhD
Institute for Cardiovascular Diseases Dedinje
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2024
First Posted
April 11, 2024
Study Start
September 1, 2023
Primary Completion
January 1, 2026
Study Completion
January 1, 2026
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share