Blood Transfusions in Coronary Artery Bypass Surgery
Blood Transfusions May Impair Endothelium-dependent Vasodilatation in Isolated Left Mammary Arterial Artery Rings and Peripheral Artery Tonometry During Coronary Artery Bypass Surgery
1 other identifier
observational
95
1 country
1
Brief Summary
The hemolytic product free-hemoglobin (fHb) reduces nitric oxide (NO) bioavailability. The present study aims to establish whether transfusions of stored allogenic blood or intraoperative autologous salvaged blood result in increased circulating fHb levels and NO consumption with effects on arterial NO-dependent blood flow measured in isolated left mammary artery rings and by peripheral artery tonometry in patients undergoing CABG surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 16, 2016
CompletedFirst Posted
Study publicly available on registry
November 3, 2016
CompletedNovember 3, 2016
October 1, 2016
4 months
October 16, 2016
November 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in free hemoglobin plasma level (mg/dl)
analyzed by derivative spectrometry
1) beginning of surgery, 2) after 12 hours
Secondary Outcomes (3)
Endothelium-dependent arterial relaxation (in vitro)
after 12 hours
Endothelium-dependent arterial relaxation (in vivo)
after 12 hours
Change in Nitric oxyde consumption (umol/l)
1) beginning of surgery, 2) after 12 hours
Study Arms (3)
Stored Blood Cells
Blood transfusion: Stored blood cells transfused patients
Autologous Salvaged Blood
Blood transfusion: Autologous salvaged blood transfused patients
Control
Blood transfusion: No transfusion patients
Interventions
blood transfusion different sources
Eligibility Criteria
consecutive patients undergoing elective isolated CABG with cardiopulmonary bypass (CPB) at our institution between January 2014 and May 2014.
You may qualify if:
- elective CABG surgery
You may not qualify if:
- vasopressors/inotropes during surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Azienda Ospedalieva Universitaria Integrata
Verona, 37126, Italy
Biospecimen
blood, left internal mammary artery (discared rings)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alessio Rungatscher, MD, PhD
Universita di Verona
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, FAHA
Study Record Dates
First Submitted
October 16, 2016
First Posted
November 3, 2016
Study Start
January 1, 2014
Primary Completion
May 1, 2014
Study Completion
December 1, 2015
Last Updated
November 3, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share