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| Name | Class |
|---|---|
| CSL Behring | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibrinogen concentrate | Active Comparator |
| |
| Cryoprecipitate | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibrinogen concentrate | Drug | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Incor - Heart Institute - University of Sao Paulo | São Paulo | São Paulo | 05403000 | Brazil |
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| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005340 | Fibrinogen |
| C026912 | cryoprecipitate coagulum |
| ID | Term |
|---|---|
| D000209 | Acute-Phase Proteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Cryoprecipitate | Drug | 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 |
|
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 |
| D001779 |
| Blood Coagulation Factors |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |