- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03245502
The Effect of Blood Transfusion on Venoarterial PCO2 Difference in Cardiac Surgery
December 14, 2017 updated by: Büşra Tezcan, Turkiye Yuksek Ihtisas Education and Research Hospital
Venoarterial CO2 difference(delta PCO2), lactate, central venous oxygen saturation(ScVO2) will be recorded in several steps in coronary artery bypass graft and valvular cardiac operations.
The patients will be divided into two groups as Transfused, and Non-Transfused Groups observationally.
The trend of delta CO2, lactate, ScVO2, postoperative creatinine values, postoperative complications and 28 days mortality will be compared.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Preoperative creatinine values, demographic data, comorbidities will be recorded in ASA I-II elective coronary artery and valvular cardiac surgery patients.
Intraoperative delta PCO2, lactate, ScVO2 will be recorded in several steps.
The patients will be divided into two groups as Transfused, and Non-Transfused Groups observationally.
The trend of delta CO2, lactate, ScVO2, postoperative creatinine values, postoperative complications and 28 days mortality will be compared.
Study Type
Observational
Enrollment (Actual)
127
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey, 06230
- Turkiye Yuksek Ihtisas Education and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
18-75 years cardiac surgery patients
Description
Inclusion Criteria:
- Elective cardiac surgery, stable cardiac function
Exclusion Criteria:
- Clinical signs of heart failure, symptomatic cerebral or peripheral failure, uncontrolled diabetes mellitus
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Transfused
Patients who have blood transfusion during cardiac surgery
|
The transfusion of erythrocyte suspension
|
|
Not-Transfused
Patients who don't have blood transfusion during cardiac surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Complication
Time Frame: 5 days
|
The postoperative neurologic, renal, hepatic, respiratory complications
|
5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality
Time Frame: 28 days
|
mortality
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Demet Bölükbaşı, Specialist, Turkiye Yuksek Ihtisas Education and Research Hospital
- Study Director: Sema Turan, Asc prof, Turkiye Yuksek Ihtisas Education and Research Hospital
- Study Chair: Dilek Kazancı, Asc prof, Turkiye Yuksek Ihtisas Education and Research Hospital
- Study Chair: Sultan Sevim Yakın, Specialist, Turkiye Yuksek Ihtisas Education and Research Hospital
- Study Chair: Hija Yazıcıoğlu, Asc Prof, Turkiye Yuksek Ihtisas Education and Research Hospital
- Study Director: Aysegül Özgok, Prof, Turkiye Yuksek Ihtisas Education and Research Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 20, 2017
Primary Completion (ACTUAL)
November 1, 2017
Study Completion (ACTUAL)
December 1, 2017
Study Registration Dates
First Submitted
August 8, 2017
First Submitted That Met QC Criteria
August 9, 2017
First Posted (ACTUAL)
August 10, 2017
Study Record Updates
Last Update Posted (ACTUAL)
December 18, 2017
Last Update Submitted That Met QC Criteria
December 14, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1297
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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