C.Surgical Procedure; Cardiac, Blood Coagulation Disorders, Hypofibrinogenemia
Conditions
Keywords
Cardiac surgical procedures, Fibrinogen, Bleeding
Brief summary
The purporse of this study is evaluate whether fibrinogen concentrate reduces postoperative bleeding in pediatric cardiac surgery with cardiopulmonary by-pass.
Detailed description
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.
Interventions
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.
OTHERcontrol
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.
Sponsors
Filomena R B G Galas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The amount of postoperative bleeding | Within 7 days after cardiac surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of acute kidney injury | within 28 days after cardiac surgery | According to pediatric RIFLE, will be measured daily. |
| Rate of cardiac complications | within 28 days after cardiac surgery | Occurrence of arrhythmias, low cardiac output, cardiogenic shock and the need of postoperative ventricular assistance |
| Rate of neurological complications | within 28 days after cardiac surgery | Incidence of stroke |
| Rate of infection complications | within 28 days after cardiac surgery | Infection (surgical wound infection, pneumonia, urinary tract infection and bloodstream infection), sepsis, severe sepsis and septic shock. |
| Correlation between clot firmness (FIBTEM) and plasma fibrinogen | After the cardiopulmonary bypass (CPB) weaning and after drug administration during the surgery. | Relationship among the results of FIBTEM-A10 and plasma fibrinogen level will be performed at the same time |
| Evaluation of the clot firmness before and after the intervention | After the cardiopulmonary bypass (CPB) weaning and after drug administration during the surgery. | Evaluation between FIBTEM-A10 that will be measured after the cardiopulmonary bypass (CPB) weaning and after drug intervention |
| The amount and type of blood transfusion | within 7 days after cardiac surgery | 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. |
| Duration of mechanical ventilation | within 28 days after cardiac surgery | number of hours in which the patient reiman intubated between the date of surgery and discharge from the ICU |
| Length of vasoactive drugs | within 28 days after cardiac surgery | number of hours in which the patient will use vasoactive drugs between the date of surgery and discharge from the ICU |
| Length of ICU stay | within 28 days after cardiac surgery | number of days between the admission and discharge from the ICU. |
| Length of hospital stay | within 28 days after cardiac surgery | number of days between the date of surgery and hospital discharge. |
| Rate of mortality | within 28 days after cardiac surgery | Death from all causes occurring up to 28 days after surgery. |
| Evaluation of plasma fibrinogen before and after the intervention | After the cardiopulmonary bypass (CPB) weaning, after drug administration during the surgery and in ICU admission. | Evaluation between the fibrinogen level that will be measured after the cardiopulmonary bypass (CPB) weaning, after drug intervention and in the ICU admission. |
Countries
Brazil
Contacts
Primary ContactFilomena RG Galas
Outcome results
None listed