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Remote Ischemic Preconditioning on Brain Injury in Carotid Endarterectomy

Primary Purpose

Brain Injuries, Remote Ischemic Preconditioning

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Remote Ischemic Preconditioning
Control
Sponsored by
The Affiliated Hospital of Xuzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Brain Injuries

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Affiliated Hospital of Xuzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Remote Ischemic Preconditioning(RIPC)

Control

Arm Description

RIPC 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

Control group without remote ischemic preconditioning

Outcomes

Primary Outcome Measures

S100-beta biomarker
tested by ELISA

Secondary Outcome Measures

Short - term cognitive function
Short - term cognitive function will be tested by mini-mental state examination
Neuron specific enolase (NSE) biomarker
tested by ELISA
Sleep quality
Sleep quality will be test by medical outcomes study sleep scale

Full Information

First Posted
January 17, 2017
Last Updated
March 9, 2017
Sponsor
The Affiliated Hospital of Xuzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03027011
Brief Title
Remote Ischemic Preconditioning on Brain Injury in Carotid Endarterectomy
Official Title
Effect of Remote Ischemic Preconditioning on Brain Injury in Carotid Endarterectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Hospital of Xuzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Remote Ischemic Preconditioning

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remote Ischemic Preconditioning(RIPC)
Arm Type
Active Comparator
Arm Description
RIPC 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
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Control group without remote ischemic preconditioning
Intervention Type
Procedure
Intervention Name(s)
Remote Ischemic Preconditioning
Other Intervention Name(s)
RIPC
Intervention Description
RIPC 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
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
Control group without remote ischemic preconditioning
Primary Outcome Measure Information:
Title
S100-beta biomarker
Description
tested by ELISA
Time Frame
48 hours post surgery
Secondary Outcome Measure Information:
Title
Short - term cognitive function
Description
Short - term cognitive function will be tested by mini-mental state examination
Time Frame
1 day before surgery and 1 week post surgery
Title
Neuron specific enolase (NSE) biomarker
Description
tested by ELISA
Time Frame
48 hours post surgery
Title
Sleep quality
Description
Sleep quality will be test by medical outcomes study sleep scale
Time Frame
1 week post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Xiuxia, MD
Phone
+86-18052268332
Email
cxxlxy@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen Xiuxia, MD
Organizational Affiliation
The Affiliated Hospital of Xuzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Xiuxia, MD
Phone
+86-18052268332
Email
cxxlxy@sina.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will be available when this trial is finished and the article have been published
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Remote Ischemic Preconditioning on Brain Injury in Carotid Endarterectomy

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