Effects of Heating Transfusion on Brain Function | NCT01930305

Studies
Effects of Heating Transfusion on Brain Function

NCT01930305

Sponsor

General Hospital of Ningxia Medical University

Status

Completed

Last Update Posted

Jul 11, 2014Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Blood Transfusion

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Dec 2013Actual

Completion Date

Jan 2014Actual

First Submitted Date

Jul 17, 2013

First Submission Date that Met QC Criteria

Aug 23, 2013

First Posted Date

Aug 28, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2014

Last Update Posted Date

Jul 11, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
the cognitive performance and the score of postoperative quality recovery scales ( PQRS)		Chang from baseline at 15min,40min,1day,3day and 7day postoperative lay

Other Outcomes

Measure	Description	Time Frame
serum concentration of inflammatory cytokine		change from baseline at 3hour, 6hour, 12hour, 24hour after transfusion

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

adult paitents scheduled for major surgery.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xinli Ni	Ningxia Medical University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
General Hospital of Ningxia Medical University		Yinchuan	Ningxia	750004	China
Ningxia Medical University