Clinical Trial of Remote Preconditioning in Patients Undergoing Cervical Decompression Surgery

This study has been completed.
Sponsor:
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT00778323
First received: August 9, 2008
Last updated: February 24, 2011
Last verified: November 2008
  Purpose

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.


Condition Intervention Phase
Cervical Compression Myelopathy
Ischemia
Reperfusion Injury
Spinal Cord Injury
Procedure: limb remote ischemic preconditioning (LRIPC)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Remote Ischemic Preconditioning on Biochemical Markers and Neurological Outcomes in Patients Undergoing Elective Cervical Decompression Surgery

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • serum concentrations of s-100B,NSE [ Time Frame: 1 week or more ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • a Japanese Orthopaedic Association (JOA) scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: September 2007
Study Completion Date: April 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A,2, II 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.
Other Name: an automated cuff-inflator made in China

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 and NSE concentration will be measured before and after induction ,and at 6 hours,1,3,5 and 7days after surgery.JOA scores in all the cases will be evaluated before operation and at 7days ,1,3,6 month after surgery.

  Eligibility

Ages Eligible for Study:   30 Years to 75 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 30-75
  • Stage 1-2

Exclusion Criteria:

  • Age>75
  • History of heart,hepatic,renal or pulmonary disease.
  • History of peripheral vascular disease affecting the upper limbs.
  Contacts and Locations
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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 by Xijing Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lize Xiong, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT00778323     History of Changes
Other Study ID Numbers: XJ20070901
Study First Received: August 9, 2008
Last Updated: February 24, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
remote ischemic preconditioning
cervical compression myelopathy
spinal cord
neuron-specific enolase
s-100B

Additional relevant MeSH terms:
Spinal Cord Diseases
Bone Marrow Diseases
Reperfusion Injury
Spinal Cord Injuries
Cardiovascular Diseases
Central Nervous System Diseases
Hematologic Diseases
Nervous System Diseases
Pathologic Processes
Postoperative Complications
Trauma, Nervous System
Vascular Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on October 22, 2014