Clinical trial NCT03884725: Fibrinogen Concentrate In Children Cardiac Surgery 2
Official title: Profilatic Fibrinogen Concentrate Reduces Postoperative Bleeding in Pediatric Cardiac Surgery With Cardiopulmonary Bypass: Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: C.Surgical Procedure; Cardiac
Blood Coagulation Disorders
Hypofibrinogenemia
Keywords: Cardiac surgical procedures
Fibrinogen
Bleeding
Lead sponsor: Instituto do Coracao
Sponsor class: OTHER_GOV
First posted: 2019-03-21
Enrollment: 42
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: The amount of postoperative bleeding
timeFrame: Within 7 days after cardiac surgery
Secondary outcomes:
measure: The amount and type of blood transfusion
timeFrame: within 7 days after cardiac surgery
measure: Rate of acute kidney injury
timeFrame: within 28 days after cardiac surgery
measure: Rate of cardiac complications
timeFrame: within 28 days after cardiac surgery
measure: Rate of neurological complications
timeFrame: within 28 days after cardiac surgery
measure: Rate of infection complications
timeFrame: within 28 days after cardiac surgery
measure: Correlation between clot firmness (FIBTEM) and plasma fibrinogen
timeFrame: After the cardiopulmonary bypass (CPB) weaning and after drug administration during the surgery.
measure: Evaluation of the clot firmness before and after the intervention
timeFrame: After the cardiopulmonary bypass (CPB) weaning and after drug administration during the surgery.
measure: Evaluation of plasma fibrinogen before and after the intervention
timeFrame: After the cardiopulmonary bypass (CPB) weaning, after drug administration during the surgery and in ICU admission.
measure: Duration of mechanical ventilation
timeFrame: within 28 days after cardiac surgery
measure: Length of vasoactive drugs
timeFrame: within 28 days after cardiac surgery
measure: Length of ICU stay
timeFrame: within 28 days after cardiac surgery
measure: Length of hospital stay
timeFrame: within 28 days after cardiac surgery
measure: Rate of mortality
timeFrame: within 28 days after cardiac surgery
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Incor - Heart Institute - University of Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Filomena RG Galas
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.