Effects of Heating Transfusion on Brain Function

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

    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • General Hospital of Ningxia Medical University
      • Yinchuan, Ningxia, China, 750004
        • Ningxia Medical University

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
Brain function includes cerebral blood flow and cerebral oxygen saturation
Change from baseline at post-transfusion 15min, 30min, 1hour, 2hour, 3 hour, 6hour, 12hour, 24hour

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
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
change from baseline at 3hour, 6hour, 12hour, 24hour after transfusion

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

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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