- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01930305
Effects of Heating Transfusion on Brain Function
July 10, 2014 updated by: General Hospital of Ningxia Medical University
Effects of Heating Transfusion on Brain Function of Surgical Patients
To inversitage whether routine warming of blood is harmful to brain fuction of sugical patients receiving massive transfusion.
Study Overview
Status
Completed
Conditions
Detailed Description
Hypothermia is an effective therapeutic intervention to reduce hypoxic ischemia brain injury in animal experiments and in clinics.In a recent study, it has been shown that perioperative warming was associated with a higher incidence of cognitive dysfunction in elderly patients.Therefore, we hypothesised that perioperative heating transfusion have a side effect on brain function of surgical patients.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ningxia
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Yinchuan, Ningxia, China, 750004
- General Hospital of Ningxia Medical University
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Yinchuan, Ningxia, China, 750004
- Ningxia Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
adult paitents scheduled for major surgery.
Description
Inclusion Criteria:
- adult patients scheduled for major surgery under general anesthesia and they probably need a blood transfusion during the procedure.
Exclusion Criteria:•Patients with a history of stroke, central nervous system disease , metabolic disturbance, psychiatric illness, hearing impairment, drug abuse or unwilling to participate in assessment
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain fuction during perioperative period
Time Frame: Change from baseline at post-transfusion 15min, 30min, 1hour, 2hour, 3 hour, 6hour, 12hour, 24hour
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Brain function includes cerebral blood flow and cerebral oxygen saturation
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Change from baseline at post-transfusion 15min, 30min, 1hour, 2hour, 3 hour, 6hour, 12hour, 24hour
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the cognitive performance and the score of postoperative quality recovery scales ( PQRS)
Time Frame: Chang from baseline at 15min,40min,1day,3day and 7day postoperative lay
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Chang from baseline at 15min,40min,1day,3day and 7day postoperative lay
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
serum concentration of inflammatory cytokine
Time Frame: change from baseline at 3hour, 6hour, 12hour, 24hour after transfusion
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change from baseline at 3hour, 6hour, 12hour, 24hour after transfusion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Xinli Ni, Ningxia Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
July 17, 2013
First Submitted That Met QC Criteria
August 23, 2013
First Posted (Estimate)
August 28, 2013
Study Record Updates
Last Update Posted (Estimate)
July 11, 2014
Last Update Submitted That Met QC Criteria
July 10, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NXKJGG2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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