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CompletedNCT03291769Updated Oct 17, 2019

Effects of Intraoperative Blood and Blood Product Consumption on Postoperative Results in Pediatric Cardiac Surgery

An observational study in Blood Loss, Surgical and Pediatric Heart Surgery, sponsored by Cukurova University. Completed at 1 site in Turkey. Open to participants aged 1 Day to 16 Years. Per ClinicalTrials.gov, last updated 2019-10-17.

Sponsored by Cukurova University · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
83
Ages
1 Day to 16 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Blood Loss, Surgical
  • Pediatric Heart Surgery

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03

In context

Blood Loss, Surgical

213 studies on the registry are indexed under Blood Loss, Surgical; 40 are open to participants now.

This study's enrollment of 83 is below the median of 154 across 43 observational studies indexed under Blood Loss, Surgical.

Browse Blood Loss, Surgical studies →

Lead sponsor

Cukurova University is the lead sponsor of 260 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 16 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Children aged 16 years or younger who will undergo heart surgery due to congenital heart disease will be included in the study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Children with renal failure
  • Children with hepatic disease
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
83 participants (actual)
Target follow-up
10 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Length of stay in intensive care unit

    Postoperative length of stay in intensive care unit

    Time frame: Postoperative 3 months

Secondary outcomes

  1. Mortality

    Postoperative mortality

    Time frame: Postoperative 3 months

07

Study locations

1 site
  • Feri̇de Karacaer
    Adana, In The USA Or Canada, Please Select... 01330, Turkey
08

References and documents

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 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in Aug 2018, 5 months.

Of 23 observational studies under Blood Loss, Surgical, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 60. This study's 5 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 23, 2017
First posted
Sep 25, 2017
StartActual
Mar 25, 2018
Primary completionActual
Aug 25, 2018
CompletionActual
Dec 25, 2018
Last update
Oct 17, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03291769
Responsible party
Feride Karacaer (Specialist doctor, Cukurova University) — Principal investigator
First posted
Sep 25, 2017
Start date
Mar 25, 2018
Primary completion
Aug 25, 2018
Completion
Dec 25, 2018
Last update
Oct 17, 2019

Study contacts

Feri̇de Karacaer
study director · Cukurova University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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