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The purporse of this study is evaluate whether fibrinogen concentrate reduces postoperative bleeding in pediatric cardiac surgery with cardiopulmonary by-pass.
Cardiac surgery in children may be associated with excessive perioperative bleeding. Perioperative excessive bleeding is associated with need of transfusion with allogeneic blood products such as red blood cells, fresh frozen plasma, platelet pools, and cryoprecipitate. Furthermore, bleeding may result in re-exploration, which is associated with increased morbidity and mortality.Recent studies have shown that patients and children undergoing cardiac surgery with pump often experience a significant drop in their levels and function of fibrinogen, and it would be in part responsible for the bleeding. Fibrinogen concentrate (Haemocomplettan P)may reduce perioperative bleeding, requirements of blood transfusion and clinical outcomes in children undergoing cardiac surgery with pump.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fibrinogen concentrate | Active Comparator | patients randomized to fibrinogen group receive intravenous infusion of drug prepared based on ROTEM measurement of maximum clot firmness (MCF) |
|
| control | Placebo Comparator | patients randomized to the control group will receive the infusion of 0.9% saline (SF0,9%) prepared based on ROTEM measurement of maximum clot firmness (MCF) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibrinogen Concentrate | Drug | Fibrinogen Concentrate is to be administered as an intravenous infusion after discontinuation of cardiopulmonary bypass and administration of protamine. Subjects are to be given Fibrinogen Concentrate at an individually determined dose based on FIBTEM MCF and body weight as follows: (15 [mm] - MCF [mm]) * body weight [kg] / 140 [mm*kg/g] = gram fibrinogen to be dosed as Fibrinogen Concentrate. Fibrinogen Concentrate is to be infused over 1 to 2 minutes. After Fibrinogen Concentrate infusion, bleeding treatment will follow the predefined, standardized treatment regimen. |
| Measure | Description | Time Frame |
|---|---|---|
| The amount of postoperative bleeding | The amount of blood loss (tube drainage) in the first 6 hours of ICU admission and daily until the seventh day of ICU. Re-exploration is mandatory if the patient presente excessive bleeding not responsive to clinical measures (warming, coagulopathy correction and/or thrombocytopenia correction), associated hemodynamic instability or evidence of cardiac tamponade. | Within 7 days after cardiac surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The amount and type of blood transfusion | The amount and type of intraoperative blood transfusion within the first 6 hours of ICU admission and daily up to the seventh day of ICU. | within 7 days after cardiac surgery |
| Rate of acute kidney injury |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Filomena RG Galas | Contact | +551126615232 | filomenagalas@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Filomena RG Galas | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Incor - Heart Institute - University of Sao Paulo | Recruiting | São Paulo | 05403000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24951020 | Result | Galas FR, de Almeida JP, Fukushima JT, Vincent JL, Osawa EA, Zeferino S, Camara L, Guimaraes VA, Jatene MB, Hajjar LA. Hemostatic effects of fibrinogen concentrate compared with cryoprecipitate in children after cardiac surgery: a randomized pilot trial. J Thorac Cardiovasc Surg. 2014 Oct;148(4):1647-55. doi: 10.1016/j.jtcvs.2014.04.029. Epub 2014 Apr 18. |
| Label | URL |
|---|---|
| Bleeding, Bleeding Disorders, Heart Surgery | View source |
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| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| D000347 | Afibrinogenemia |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D025861 | Blood Coagulation Disorders, Inherited |
| D020147 | Coagulation Protein Disorders |
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| ID | Term |
|---|---|
| D005340 | Fibrinogen |
| ID | Term |
|---|---|
| D000209 | Acute-Phase Proteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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|
| control | Other | 0.9% saline is to be administered as an intravenous infusion after discontinuation of cardiopulmonary bypass and administration of protamine. Patients randomized to the control group will receive the infusion of 0.9% saline (SF0,9%) prepared based on ROTEM measurement of maximum clot firmness (MCF). 0.9% saline is to be infused over 1 to 2 minutes. After 0.9% saline infusion, bleeding treatment will follow the predefined, standardized treatment regimen. |
|
According to pediatric RIFLE, will be measured daily.
| within 28 days after cardiac surgery |
| Rate of cardiac complications | Occurrence of arrhythmias, low cardiac output, cardiogenic shock and the need of postoperative ventricular assistance | within 28 days after cardiac surgery |
| Rate of neurological complications | Incidence of stroke | within 28 days after cardiac surgery |
| Rate of infection complications | Infection (surgical wound infection, pneumonia, urinary tract infection and bloodstream infection), sepsis, severe sepsis and septic shock. | within 28 days after cardiac surgery |
| Correlation between clot firmness (FIBTEM) and plasma fibrinogen | Relationship among the results of FIBTEM-A10 and plasma fibrinogen level will be performed at the same time | After the cardiopulmonary bypass (CPB) weaning and after drug administration during the surgery. |
| Evaluation of the clot firmness before and after the intervention | Evaluation between FIBTEM-A10 that will be measured after the cardiopulmonary bypass (CPB) weaning and after drug intervention | After the cardiopulmonary bypass (CPB) weaning and after drug administration during the surgery. |
| Evaluation of plasma fibrinogen before and after the intervention | Evaluation between the fibrinogen level that will be measured after the cardiopulmonary bypass (CPB) weaning, after drug intervention and in the ICU admission. | After the cardiopulmonary bypass (CPB) weaning, after drug administration during the surgery and in ICU admission. |
| Duration of mechanical ventilation | number of hours in which the patient reiman intubated between the date of surgery and discharge from the ICU | within 28 days after cardiac surgery |
| Length of vasoactive drugs | number of hours in which the patient will use vasoactive drugs between the date of surgery and discharge from the ICU | within 28 days after cardiac surgery |
| Length of ICU stay | number of days between the admission and discharge from the ICU. | within 28 days after cardiac surgery |
| Length of hospital stay | number of days between the date of surgery and hospital discharge. | within 28 days after cardiac surgery |
| Rate of mortality | Death from all causes occurring up to 28 days after surgery. | within 28 days after cardiac surgery |
| Fibrinogen Concentrate | View source |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001779 |
| Blood Coagulation Factors |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |