Cardiac Surgical Procedures, Blood Coagulation Disorders, Fibrinogen, Cryoprecipitate
Conditions
Keywords
Cardiac surgical procedures, Fibrinogen, Bleeding, Cryoprecipitate
Brief summary
The purpose of this study is to evaluate prospectively whether concentrate fibrinogen reduces blood losses, transfusion requirements and occurrence of clinical complications compared to cryoprecipitate in children after cardiac surgery with pump.
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. In most centre world-wide, it is common practice to treat bleeding in these patients with cryoprecipitate in order to substitute fibrinogen. Fibrinogen concentrate (Haemocomplettan P)may reduce perioperative bleeding, requirements of blood transfusion and clinical outcomes in children undergoing cardiac surgery with pump, compared to cryoprecipitate.
Interventions
In this arm, children (\< 18 year-old)undergoing cardiac surgery with pump will receive fibrinogen concentrate (60 mg/Kg) if they present clinically significant bleeding associated to low levels of fibrinogen (\< 1g/L) or TEG \< 7 mm
DRUGCryoprecipitate
In this arm, children (\< 18 year-old)undergoing cardiac surgery with pump will receive cryoprecipiate (10 ml/Kg) if they present clinically significant bleeding associated to low levels of fibrinogen (\< 1g/L) or TEG \< 7 mm
Sponsors
CSL Behring
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Cardiac surgery with pump * Age until 18 years * Written informed consent * Clinically important bleeding in intraoperative * Fibrinogen lower than 1 g/L or TEG \< 7 mm
Exclusion criteria
* Previous coagulopathy (clinical history or INR \> 1.5) * Low platelet count (lower than 100.000) * Product allergy * Urgent procedures * Active infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients receiving any allogeneic blood products | From ICU admission until hospital discharge | Percentage of patients exposed to allogeneic blood products (red blood cells, FFP, platelet concentrate and cryoprecipitate) after ICU admission until hospital discharge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical complications - renal failure, respiratory failure,sepsis, myocardial ischemia, stroke | Up to hospital discharge | Clinical complications since intraoperative until hospital discharge |
| Mechanical ventilation free-days | Up to ICU discharge | Number of days without mechanical ventilation during ICU stay |
| Length of hospital stay | Up to hospital discharge | Number of days since arrival at ICU until hospital discharge |
| Length of ICU stay | Up to ICU discharge | Length of ICU stay - days since arrival at ICU until discharge |
| intraoperative transfusion | intraoperative period | intraoperative requirements of any blood product (red blood cells, FFP, platelet concentrate and cryoprecipitate)) |
| postoperative blood losses | from ICU admission until hospital discharge | postoperative blood losses determined by the weight of dressings at intraoperative and chest tube drainage 12h and 24h after ICU admission |
| Vasopressors free-days | Up to ICU discharge | Number of days without vasopressors during ICU stay |
Countries
Brazil
Outcome results
None listed