Fibrinogen Concentrate In Children After Cardiac Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fibrinogen Concentrate to Treat Bleeding in Children Undergoing Cardiac Surgery With Pump: a Randomised Controlled Clinical Trial

Conditions
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Cardiac Surgical Procedures, Blood Coagulation Disorders, Fibrinogen, Cryoprecipitate

Intervention / Treatment
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* Drug: Fibrinogen concentrate
* Drug: Cryoprecipitate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fibrinogen concentrate<br> | Drug: Fibrinogen concentrate<br>* 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<br>* Other names: Haemocompletan;|
| Active Comparator: Cryoprecipitate<br> | Drug: Cryoprecipitate<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients receiving any allogeneic blood products | Percentage of patients exposed to allogeneic blood products (red blood cells, FFP, platelet concentrate and cryoprecipitate) after ICU admission until hospital discharge. | From ICU admission until hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of ICU stay | Length of ICU stay - days since arrival at ICU until discharge | Up to ICU discharge | 
| Clinical complications - renal failure, respiratory failure,sepsis, myocardial ischemia, stroke | Clinical complications since intraoperative until hospital discharge | Up to hospital discharge | 
| Mechanical ventilation free-days | Number of days without mechanical ventilation during ICU stay | Up to ICU discharge | 
| Length of hospital stay | Number of days since arrival at ICU until hospital discharge | Up to hospital discharge | 
| Vasopressors free-days | Number of days without vasopressors during ICU stay | Up to ICU discharge | 
| intraoperative transfusion | intraoperative requirements of any blood product (red blood cells, FFP, platelet concentrate and cryoprecipitate)) | intraoperative period | 
| postoperative blood losses | postoperative blood losses determined by the weight of dressings at intraoperative and chest tube drainage 12h and 24h after ICU admission | from ICU admission until hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac surgical procedures, Fibrinogen, Bleeding, Cryoprecipitate