Blood Coagulation Disorders Clinical Trial
— FiCCS2Official title:
Profilatic Fibrinogen Concentrate Reduces Postoperative Bleeding in Pediatric Cardiac Surgery With Cardiopulmonary Bypass: Randomized Study
The purporse of this study is evaluate whether fibrinogen concentrate reduces postoperative bleeding in pediatric cardiac surgery with cardiopulmonary by-pass.
Status | Recruiting |
Enrollment | 42 |
Est. completion date | June 2019 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 10 Years |
Eligibility |
Inclusion Criteria: - Cardiac surgery with pump - Written informed consent - Age under 28 days of life or RACHS-1 equal or greater than 3 or reoperation with age under 10 years Exclusion Criteria: - Coagulopathy (INR > 1.5) - Low platelet count (lower than 100.000) - Product or albumin allergy - Active endocarditis - Blalock-Taussig - Heart transplant - Anemia (hemoglobin < 10 g/dL) - Impossibility to receive blood transfusion - Hepatic dysfunction (total bilirubin > 1.5 mg/dL) - Known or suspected hypersensitivity to fibrinogen concentrate - Thrombophilia or previous thrombosis - Participation in another study |
Country | Name | City | State |
---|---|---|---|
Brazil | Incor - Heart Institute - University of Sao Paulo | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Filomena R B G Galas |
Brazil,
Galas FR, de Almeida JP, Fukushima JT, Vincent JL, Osawa EA, Zeferino S, Câmara L, Guimarães VA, Jatene MB, Hajjar LA. Hemostatic effects of fibrinogen concentrate compared with cryoprecipitate in children after cardiac surgery: a randomized pilot trial. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | Rate of acute kidney injury | According to pediatric RIFLE, will be measured daily. | within 28 days after cardiac surgery | |
Secondary | 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 | |
Secondary | Rate of neurological complications | Incidence of stroke | within 28 days after cardiac surgery | |
Secondary | 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 | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Length of ICU stay | number of days between the admission and discharge from the ICU. | within 28 days after cardiac surgery | |
Secondary | Length of hospital stay | number of days between the date of surgery and hospital discharge. | within 28 days after cardiac surgery | |
Secondary | Rate of mortality | Death from all causes occurring up to 28 days after surgery. | within 28 days after cardiac surgery |
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