NCT01930305

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 28, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

July 11, 2014

Status Verified

July 1, 2014

Enrollment Period

1.5 years

First QC Date

July 17, 2013

Last Update Submit

July 10, 2014

Conditions

Blood Transfusion

Keywords

Heating transfusion

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • 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 (1)

  • serum concentration of inflammatory cytokine

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

adult paitents scheduled for major surgery.

You may qualify if:

  • adult patients scheduled for major surgery under general anesthesia and they probably need a blood transfusion during the procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

Study Officials

  • Xinli Ni

    Ningxia Medical University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2013

First Posted

August 28, 2013

Study Start

June 1, 2012

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

July 11, 2014

Record last verified: 2014-07

Locations

CN(2)