Clinical Trial of Remote Preconditioning in Patients Undergoing Cervical Decompression Surgery - Full Text View

Sponsored by:	Xijing Hospital
Information provided by:	Xijing Hospital
ClinicalTrials.gov Identifier:	NCT00778323

Purpose

The purpose of this study is to determine whether LRIPC reduces spinal cord injury in patients undergoing elective cervical decompression surgery.

Condition	Intervention	Phase
Cervical Compression Myelopathy Ischemia Reperfusion Injury Spinal Cord Injury	Procedure: limb remote ischemic preconditioning (LRIPC)	Phase I Phase II

MedlinePlus related topics: Spinal Cord Injuries Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Study of Effect of Limb Remote Ischemic Preconditioning on Spinal Cord Injury in Patients Undergoing Elective Cervical Decompression Surgery

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:

serum concentrations of s-100b,NSE,MDA and SOD [ Time Frame: 1 week or more ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

a modified Japanese Orthopaedic Association (mJOA) scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	September 2007
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A,2, II: Experimental	Procedure: limb remote ischemic preconditioning (LRIPC) 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.

Detailed Description:

Spinal cord ischemia-reperfusion injury commonly contribute to perioperative morbidity and mortality after elective cervical decompression surgery.Remote ischemic preconditioning(RIPC)is a phenomenon whereby brief periods of ischemia followed by reperfusion in one organ provide system protection from prolonged ischemia.The hypothesis of this protocol is that limb ischemic preconditioning could reduces spinal cord ischemia-reperfusion injury induced by elective cervical decompression surgery.Serum s-100b,MDA,SOD and NSE concentration will be measured before and after induction ,and at 6,24,72,120,168h after surgery.JOA scores and somatosensory evoked potential(SEP)in all the cases will be evaluated before operation and at 6,24,72,120,168h,1,3,6 month after surgery.

Eligibility

Ages Eligible for Study:	30 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with clinical and radiological signs of cervical compression myelopathy(ccm)
Age 30-70
Stage 1-2

Exclusion Criteria:

Age>70
History of heart,hepatic,renal or pulmonary disease.
History of peripheral vascular disease affecting the upper limbs.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00778323

Locations

China, Shaanxi
Xijing Hospital
Xi'an, Shaanxi, China, 710032

Sponsors and Collaborators

Xijing Hospital

Investigators

Study Chair:

Lize Xiong, MD

Xiling Hospital,Fourth Military Medical University

More Information

No publications provided

Responsible Party:	Fourth Military Medical University ( Lize Xiong )
Study ID Numbers:	XJ20070901
Study First Received:	August 9, 2008
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00778323 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Xijing Hospital:

cervical compression myelopathy
preconditioning
ischemia
reperfusion injury
spinal cord injury

neuron-specific enolase
s-100b
NSE
MDA
SOD

Study placed in the following topic categories:

Spinal Cord Injuries
Spinal Cord Diseases
Postoperative Complications
Wounds and Injuries
Vascular Diseases

Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System
Ischemia
Reperfusion Injury

Additional relevant MeSH terms:

Spinal Cord Diseases
Nervous System Diseases
Vascular Diseases
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin
Ischemia

Trauma, Nervous System
Spinal Cord Injuries
Pathologic Processes
Postoperative Complications
Cardiovascular Diseases
Reperfusion Injury

ClinicalTrials.gov processed this record on May 07, 2009