Effects of Heating Transfusion on Brain Function

Blood Transfusion Clinical Trial

Official title:

Effects of Heating Transfusion on Brain Function of Surgical Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01930305
• Other study ID #: NXKJGG2012
• Status: Completed
• Phase: N/A
• First received: July 17, 2013
• Last updated: July 10, 2014
• Start date: June 2012
• Est. completion date: January 2014

Study information

• Verified date: July 2014
• Source: General Hospital of Ningxia Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Observational

Clinical Trial Summary

To inversitage whether routine warming of blood is harmful to brain fuction of sugical patients receiving massive transfusion.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Blood Transfusion

Locations

Country	Name	City	State
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia
China	Ningxia Medical University	Yinchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Ningxia Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	serum concentration of inflammatory cytokine		change from baseline at 3hour, 6hour, 12hour, 24hour after transfusion	Yes
Primary	Brain fuction during perioperative period	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	Yes
Secondary	the cognitive performance and the score of postoperative quality recovery scales ( PQRS)		Chang from baseline at 15min,40min,1day,3day and 7day postoperative lay	Yes