NCT00866489

Brief Summary

The current study is designed to clarify the neuroprotective effect of remote ischemic precondtioning on the patients underwent neurosurgery.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2008

Status
completed

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, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

December 28, 2010

Status Verified

March 1, 2009

Enrollment Period

9 months

First QC Date

March 19, 2009

Last Update Submit

December 26, 2010

Conditions

s100b

Keywords

Experimental

Outcome Measures

Primary Outcomes (1)

  • S-100b and NSE level

    7 days

Study Arms (2)

sham RIPC

NO INTERVENTION

Patients had a deflated cuff placed on the right upper arm for 30 min.

RIPC

EXPERIMENTAL

RIPC consisted of three 5-min cycles of right upper arm ischemia, which was induced by an automated cuff-inflator placed on the right upper arm and inflated to 200 mmHg, with an intervening 5 min of reperfusion during which the cuff was deflated

Procedure: remote preconditioning

Interventions

remote preconditioningPROCEDURE

Remote ischemic preconditioning consist of three 5-min cycles of right upper limb ischaemia, induced by an automated cuff-inflator placed on the upper arm and inflated to 200 mm Hg, with an intervening 5 min of reperfusion during which the cuff is deflated.

Also known as: remote ischemic preconditioning, RIPC
RIPC

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients referred for primary elective neurosurgery were invited to participate in the study at the time of scheduling for operation

You may not qualify if:

  • Potential participants were excluded if they were \>70 years of age
  • Required concomitant procedures other than neurosurgery
  • Had experienced an acute coronary syndrome or myocardial infraction within 3 months
  • Were unable to give informed consent
  • Were taking sulfonylurea oral hypoglycemic agents or nicorandil drug therapy because these agents have been shown to effect preconditioning.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Hailong DONG, M.D.,Ph.D.

    Xijing Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 19, 2009

First Posted

March 20, 2009

Study Start

September 1, 2008

Primary Completion

June 1, 2009

Study Completion

September 1, 2009

Last Updated

December 28, 2010

Record last verified: 2009-03