Blood Loss, SurgicalNCT03291769
Effects of Intraoperative Blood and Blood Product Consumption on Postoperative Results in Pediatric Cardiac Surgery
An observational study of Blood Loss, Surgical and Pediatric Heart Surgery, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
Blood products and intravenous fluids are frequently used in the treatment of children who have undergone cardiac surgery in order to maintain hemodynamic stability. Optimal hematocrit values during CPB are still being discussed in children undergoing congenital cardiac surgery. Read more about this study
- Who is it for?
- Ages 1 day to 16 years
- Conditions the study is for
- Blood Loss, Surgical, Pediatric Heart Surgery
- How many people
- 83 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Mar 2018to 25 Dec 2018
- How long will I take part?
- 10 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 16 years
- All sexes
- Child
Study population: Children aged 16 years or younger who will undergo heart surgery due to congenital heart disease will be included in the study.
Who may be able to join
- Children aged 16 years or younger who will undergo heart surgery due to congenital heart disease will be included in the study.
Who cannot join
- Children with renal failure
- Children with hepatic disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Feri̇de Karacaer
Adana, In the USA Or Canada, Please Select..., 01330
About this study
Official title: Effects of Intraoperative Blood Transfusion on Postoperative Results in Pediatric Cardiac Surgery
Blood products and intravenous fluids are frequently used in the treatment of children who have undergone cardiac surgery in order to maintain hemodynamic stability. Optimal hematocrit values during CPB are still being discussed in children undergoing congenital cardiac surgery. The overall complication rate for transfusion in adults is 2.5 complications per 1000 units, while 10.7 complications per 1000 transfusion in children. The aim of this study is to investigate the effects of the our transfusion strategies used in pediatric cardiac surgery on duration of intensive care unit, duration of postoperative mechanical ventilation and mortality.
Read the 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.
- Conditions
- Blood Loss, Surgical, Pediatric Heart Surgery
- Medical subject headings
- Blood Loss, Surgical
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay in intensive care unit
Postoperative length of stay in intensive care unit
Measured: Postoperative 3 months
Secondary outcomes (1)
Mortality
Postoperative mortality
Measured: Postoperative 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start25 Mar 2018
- Primary completion25 Aug 2018
- Study completion25 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Loss, SurgicalStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
- Target duration
- 10 Months
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feride Karacaer, Cukurova University
- Investigators
- Feri̇de Karacaer, Study director, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291769
- Sponsor's protocol ID
- PHS01
- Status last verified
- Oct 2019
- First submitted
- 23 Aug 2017
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rizza A, Romagnoli S, Ricci Z. Fluid Status Assessment and Management During the Perioperative Phase in Pediatric Cardiac Surgery Patients. J Cardiothorac Vasc Anesth. 2016 Aug;30(4):1085-93. doi: 10.1053/j.jvca.2015.11.007. Epub 2015 Nov 10. No abstract available.
PubMed 26944520
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intraoperative Blood Transfusion on Postoperative Results in Pediatric Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03291769
- Acronym / sponsor ID
- PHS01
- Conditions
- Blood Loss, Surgical, Pediatric Heart Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 25 Mar 2018 (actual)
- Primary completion
- 25 Aug 2018 (actual)
- Study completion
- 25 Dec 2018 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Blood products and intravenous fluids are frequently used in the treatment of children who have undergone cardiac surgery in order to maintain hemodynamic stability. Optimal hematocrit values during CPB are still being discussed in children undergoing congenital cardiac surgery. The overall complication rate for transfusion in adults is 2.5 complications per 1000 units, while 10.7 complications per 1000 transfusion in children. The aim of this study is to investigate the effects of the our transfusion strategies used in pediatric cardiac surgery on duration of intensive care unit, duration of postoperative mechanical ventilation and mortality.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Months
Who may qualify
- Ages
- 1 day to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- Children aged 16 years or younger who will undergo heart surgery due to congenital heart disease will be included in the study.
Key inclusion criteria (1 listed)
- Children aged 16 years or younger who will undergo heart surgery due to congenital heart disease will be included in the study.
Key exclusion criteria (2 listed)
- Children with renal failure
- Children with hepatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Length of stay in intensive care unit
Time frame: Postoperative 3 months
Postoperative length of stay in intensive care unit
1 secondary outcome
Mortality
Time frame: Postoperative 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- Background: PubMed 26944520Rizza A, Romagnoli S, Ricci Z. Fluid Status Assessment and Management During the Perioperative Phase in Pediatric Cardiac Surgery Patients. J Cardiothorac Vasc Anesth. 2016 Aug;30(4):1085-93. doi: 10.1053/j.jvca.2015.11.007. Epub 2015 Nov 10. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feri̇de Karacaer study director
Cukurova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Loss, Surgical and Pediatric Heart Surgery, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay in intensive care unit (time frame: Postoperative 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03291769, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2019.