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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00778323
Other study ID # XJ20070901
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received August 9, 2008
Last updated February 24, 2011
Start date September 2007
Est. completion date April 2009

Study information

Verified date November 2008
Source Xijing Hospital
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date April 2009
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 75 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention


Intervention

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.

Locations

Country Name City State
China Xijing Hospital Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary serum concentrations of s-100B,NSE 1 week or more No
Secondary a Japanese Orthopaedic Association (JOA) scale 6 months No
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