ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03291769
Recruitment Status : Not yet recruiting
First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Feride Karacaer, Cukurova University

Brief 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.

Condition or disease
Blood Loss, Surgical Pediatric Heart Surgery

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 : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Months
Official Title: Effects of Intraoperative Blood Transfusion on Postoperative Results in Pediatric Cardiac Surgery
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery




Primary Outcome Measures :
  1. Length of stay in intensive care unit [ Time Frame: Postoperative 3 months ]
    Postoperative length of stay in intensive care unit


Secondary Outcome Measures :
  1. Mortality [ Time Frame: Postoperative 3 months ]
    Postoperative mortality



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   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.
Criteria

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

Publications:
Responsible Party: Feride Karacaer, Specialist doctor, Cukurova University
ClinicalTrials.gov Identifier: NCT03291769     History of Changes
Other Study ID Numbers: PHS01
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Blood Loss, Surgical
Hemorrhage
Pathologic Processes
Intraoperative Complications