- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03291769
Effects of Intraoperative Blood and Blood Product Consumption on Postoperative Results in Pediatric Cardiac Surgery
Effects of Intraoperative Blood Transfusion on Postoperative Results in Pediatric Cardiac Surgery
Study Overview
Status
Conditions
Detailed Description
Background: Blood products and intravenous fluids are frequently used in the treatment of children who have undergone cardiac surgery in order to maintain hemodynamic stability. Children undergoing cardiac surgery with cardiopulmonary bypass (CPB) are among the greatest pediatric users of allogeneic red blood cells (RBCs), and transfusions are used in 79% of all procedures. Optimal hematocrit values during CPB are still being discussed in children undergoing congenital cardiac surgery. While it is argued that high hematocrit values provide better results in perioperative period and postoperative neurological development, it is also argued that blood products are associated with mortality and morbidity. The overall complication rate for transfusion in adults is 2.5 complications per 1000 units, while 10.7 complications per 1000 transfusion in children.
Balancing the benefits and risks of blood transfusion is a particularly complex issue, especially in children. Because many aspects of transfusion therapy in children are not well researched.
Method: This prospective, observational study will be conducted following Cukurova University Faculty of Medicine Ethics Committee approval. Children aged 16 years or younger who will undergo open heart surgery due to congenital heart disease will be included in the study. Patients with preoperative renal or hepatic disease will be excluded. Age, comorbidities, history of previous operation will be recorded. Preoperative hematocrit, biochemical parameters (blood urea nitrogen, creatinine, electrolytes), cardiac profile (angiography and echocardiography reports, diagnosis of the disease requiring the surgery) and preoperative medications, preoperative RACHS1 (risk adjustment for congenital heart disease, risk management for congenital heart disease) will be recorded.
In the intraoperative period; the haematocrit values before CPB, during CPB, after CPB and after reversal of the heparin with protamine will be recorded. Aortic cross clamp time, body temperature, urine volume and diuretic use during CPB will be recorded. Blood gas values, central venous oxygen saturation (SvO2) and lactate levels will be recorded in the intraoperative period within 30 min intervals. The amount of crystalloid and colloid, erythrocyte, fresh frozen plasma, platelet and cryoprecipitate used in the intraoperative period will be recorded. The ACT (active coagulation time) values at the beginning and at the end of the operation, the amount of applied heparin and protamine will be recorded. Vasoactive agents (dopamine, dobutamine, adrenaline, nitroglycerin) used in the intraoperative period will be recorded.
In the postoperative intensive care unit; blood gas and lactate values, hematocrit, chest tube drainage and iv fluids (crystalloid and colloid) and blood products will be recorded at postoperative 6th and 24th hours. The vasoactive agents, the inotrope score, the amount of urine and the use of diuretics will be recorded. The length of stay in intensive care unit, the duration of mechanical ventilation will be recorded.
Major complications will be identified as cardiac arrest, neurological deficit (stroke, seizure), acute renal failure requiring dialysis therapy, arrhythmia requiring permanent heart pace and multiple organ dysfunction and recorded.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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In The USA Or Canada, Please Select...
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Adana, In The USA Or Canada, Please Select..., Turkey, 01330
- Feri̇de Karacaer
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children aged 16 years or younger who will undergo heart surgery due to congenital heart disease will be included in the study.
Exclusion Criteria:
- Children with renal failure
- Children with hepatic disease
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of stay in intensive care unit
Time Frame: Postoperative 3 months
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Postoperative length of stay in intensive care unit
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Postoperative 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: Postoperative 3 months
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Postoperative mortality
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Postoperative 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Feri̇de Karacaer, Cukurova University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHS01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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