NCT00778323

Brief Summary

The purpose of this study is to assess whether a large clinical trial testing the effect of RIPC on neurologic outcome in patients undergoing elective cervical decompression surge is warranted.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 23, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

February 25, 2011

Status Verified

November 1, 2008

Enrollment Period

1.1 years

First QC Date

August 9, 2008

Last Update Submit

February 24, 2011

Conditions

Cervical Compression MyelopathyIschemiaReperfusion InjurySpinal Cord Injury

Keywords

remote ischemic preconditioningcervical compression myelopathyspinal cordneuron-specific enolases-100B

Outcome Measures

Primary Outcomes (1)

  • serum concentrations of s-100B,NSE

    1 week or more

Secondary Outcomes (1)

  • a Japanese Orthopaedic Association (JOA) scale

    6 months

Study Arms (1)

A,2, II

EXPERIMENTAL
Procedure: limb remote ischemic preconditioning (LRIPC)

Interventions

limb remote ischemic preconditioning (LRIPC)PROCEDURE

LRIPC consists of three 5-min cycles of right upper limb ischemia induced by an automated cuff-inflator placed on the upper arm and inflated to 200 mmHg,with an intervening 5 min reperfusion during which the cuff is deflated.

Also known as: an automated cuff-inflator made in China
A,2, II

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with clinical and radiological signs of cervical compression myelopathy(ccm)
  • Age 30-75
  • Stage 1-2

You may not qualify if:

  • Age\>75
  • History of heart,hepatic,renal or pulmonary disease.
  • History of peripheral vascular disease affecting the upper limbs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

  • Hu S, Dong HL, Li YZ, Luo ZJ, Sun L, Yang QZ, Yang LF, Xiong L. Effects of remote ischemic preconditioning on biochemical markers and neurologic outcomes in patients undergoing elective cervical decompression surgery: a prospective randomized controlled trial. J Neurosurg Anesthesiol. 2010 Jan;22(1):46-52. doi: 10.1097/ANA.0b013e3181c572bd.

    PMID: 19996767DERIVED

MeSH Terms

Conditions

IschemiaReperfusion InjurySpinal Cord Injuries

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesPostoperative ComplicationsSpinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Lize Xiong, MD

    Xiling Hospital,Fourth Military Medical University

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

August 9, 2008

First Posted

October 23, 2008

Study Start

September 1, 2007

Primary Completion

October 1, 2008

Study Completion

April 1, 2009

Last Updated

February 25, 2011

Record last verified: 2008-11

Locations

CN(1)