|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00879463 |
|
Date of registration:
|
09/04/2009 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Brain Tissue Oxygen Saturation and Blood Transfusion in Cardiac Surgery
INVOS |
|
Scientific title:
|
The Impact of Brain Tissue Oxygen Saturation Monitoring in Reducing the Use of Red Blood Cells in Cardiac Surgery |
|
Date of first enrolment:
|
June 2009 |
|
Target sample size:
|
150 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00879463 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Supportive Care
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Greece
| | | | | | | |
|
Contacts
|
|
Name:
|
GEORGE VRETZAKIS, M.D. PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece |
|
|
Name:
|
STAVROULA GEORGOPOULOU, M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece |
|
|
Name:
|
ATHINA KLEITSAKI, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece |
|
|
Name:
|
KONSTANTINOS STAMOULIS, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Cardiac Anesthesia Unit, Department of Anesthesiology, University Hospital of Larissa, Greece |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Cardiac operations under cardiopulmonary bypass, consequently (including
coronary-aortic bypass graft), valve replacement, surgery of the ascending aorta,
combined procedures, redo-operations)
Exclusion Criteria:
- Cardiac operations without the aid of extracorporeal circulation (ex. "off-pump"
techniques)
- Emergency operations
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Cardiac Surgery
|
|
Blood Transfusion
|
|
Intervention(s)
|
|
Procedure: Brain tissue oxygen saturation monitoring
|
|
Procedure: Transfusion according to the anesthesiologist's judgement
|
|
Primary Outcome(s)
|
|
The number of packed red cell units transfused intra-operatively
[Time Frame: one year]
|
|
Secondary Outcome(s)
|
|
The volume of any kind of intravenous fluids administered to the patient
[Time Frame: one year]
|
|
The hematocrit values at certain timeframes
[Time Frame: one year]
|
|
The INVOS values electronically and continuously
[Time Frame: one year]
|
|
The volume of urine output from the initiation to termination of CPB and to the end
[Time Frame: one year]
|
|
Secondary ID(s)
|
|
UH 1969 TT
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|