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Clinical Trials/NCT03027011
NCT03027011
Unknown
Not Applicable

Effect of Remote Ischemic Preconditioning on Brain Injury in Carotid Endarterectomy

The Affiliated Hospital of Xuzhou Medical University1 site in 1 country40 target enrollmentMarch 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Injuries
Sponsor
The Affiliated Hospital of Xuzhou Medical University
Enrollment
40
Locations
1
Primary Endpoint
S100-beta biomarker
Last Updated
9 years ago

Overview

Brief Summary

This is a randomized controlled trial designed to test an intervention (Remote ischemic preconditioning) in patients undergoing carotid endarterectomy (CEA).Remote ischemic preconditioning(RIPC) with transient upper limb ischemia/reperfusion is a novel, simple, cost-free,non-pharmacological and non-invasive strategy.The purpose of this study is to evaluate the effects of Remote Ischaemic Preconditioning on perioperative ischaemic injury in patients undergoing carotid endarterectomy compared to control intervention.The outcomes of interest include neurocognitive function,clinical outcomes,and biomarkers of brain injury.

Detailed Description

Remote ischemic preconditioning (RIPC) protocol will be induced during anesthesia by 3 cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood pressure cuff inflated to a pressure 200mmHg

Registry
clinicaltrials.gov
Start Date
March 1, 2017
End Date
December 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing carotid endarterectomy
  • Patients aged 55 years to 80 years

Exclusion Criteria

  • Inability to give informed consent
  • Known Deep venous thrombosis (DVT) in arm
  • Pre-existing lymphedema or axillary node dissection both arms
  • Arteriovenous fistula or graft in both arms
  • Left ventricular ejection fraction less than 50%
  • Diagnosis of dementia, intellectual disability, or mental illness including depression, anxiety, or schizophrenia

Outcomes

Primary Outcomes

S100-beta biomarker

Time Frame: 48 hours post surgery

tested by ELISA

Secondary Outcomes

  • Neuron specific enolase (NSE) biomarker(48 hours post surgery)
  • Short - term cognitive function(1 day before surgery and 1 week post surgery)
  • Sleep quality(1 week post surgery)

Study Sites (1)

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