Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy and Safety of Haemocomplettan® P in Patients Experiencing Microvascular Bleeding While Undergoing Elective Complex Cardiac Surgery
Brief Summary: Fibrinogen concentrate is increasingly used in cardiac surgery to reverse coagulopathy. Whether its use reduces blood loss, transfusion and occurrence of clinical adverse events remains unknown.


Options:
A: Inclusion Criteria:

* The patients will be screened according to a modified TRUST1 Transfusion Score. This score attributes 1 point to each of the following conditions:

  * Hb level \< 13.5 g/dL
  * Weight \< 77 kg
  * Female sex
  * Age \> 65 years
  * Non elective surgery
  * Serum creatinine \> 1.36 mg/dL
  * Redo operation
  * Non isolated surgery
  * Factors are hemodilution-related factors, and will not be included. Non isolated surgery is mandatory for inclusion. Patients will be included in presence of at least 1 within the remaining 4 risk factors:
  * Age \> 65 years
  * Non elective surgery
  * Serum creatinine \> 1.36 mg/dL '8Redo operation INCLUSION CRITERIA (patients randomized)

    1. Combined cardiac operation with expected CPB duration \> 90 minutes
    2. At least one additional risk factor within the following: Age \> 65 years; Non elective surgery; Serum creatinine \> 1.36 mg/dL; Redo operation

Exclusion Criteria:

1. Age \< 18 years
2. Patients under thienopyridines
3. Known coagulopathy
4. Known autoimmune disorders
5. Participation in another RCT
6. Pregnancy
7. Emergency operation
8. Baseline HCT \< 35%
9. Baseline Antithrombin \< 80%
10. BSA \< 1.7 m2

WITHDRAWAL CRITERION:

1. Lowest HCT on CPB \< 23%
2. Transfusions during CPB

   * Patients randomized and not withdrawn will be DOSED with the investigational drugs.
B: Inclusion Criteria:

* Male and female subjects ≥ 18 years
* Subjects who have received oral vitamin K-antagonist therapy
* Subjects who have acute major bleeding, defined as one of the following: life-threatening or potentially life-threatening, acute bleeding associated with a fall in hemoglobin (Hb) level ≥ 2g/dL, bleeding requiring blood product transfusion
* INR ≥ 2 within 3 hours before start of study treatment
* Informed consent has been obtained

Exclusion Criteria:

* Expected survival of less than 3 days, or expected surgery in less than 1 day
* Acute trauma for which reversal of vitamin K antagonists alone would not be expected to control the acute bleeding event
* Use of unfractionated or low molecular weight heparin use from 24 hours prior to enrollment or expected need within 24 hours after start of infusion
* For patients with ICH: Glasgow coma score (GCS) \< 7; intracerebral hematoma volume \> 30cc as assessed by ABC/21; for subdural hematomas: maximum thickness ≥ 10 mm, midline shift ≥ 5 mm; for subarachnoid hemorrhage: any evidence of hydrocephalus; infratentorial ICH location; epidural hematomas; intraventricular extension of hemorrhage; modified Rankin score (mRS) of \>3 prior to ICH
* History of thrombotic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within 3 months of enrollment
* Known history of antiphospholipid antibody syndrome or lupus anticoagulant antibodies
* Suspected or confirmed sepsis at time of enrollment
* Administration of whole blood, plasma, plasma fractions or platelets within 2 weeks prior to inclusion into the study
* Large blood vessel rupture (e.g. in advanced cancer patient)
* Pre-existing progressive fatal disease with a life expectancy of less than 2 months
* Known inhibitors to coagulation factors II, VII, IX, or X; or hereditary protein C or protein S deficiency; or heparin-induced, type II thrombocytopenia
* Treatment with any other investigational medicinal product within 30 days prior to inclusion into the study
* Presence or history of hypersensitivity to components of the study medication
* Pregnant or breast-feeding women
* Prior inclusion in this study or any other CSL Behring-sponsored Beriplex study
C: Inclusion Criteria:

* Eighteen years of age or older.
* Undergoing elective complex cardiac surgery.
* Understood and willingly given written informed consent.
* Experience clinically relevant non-surgical microvascular bleeding following removal of cardiopulmonary bypass.

Exclusion Criteria:

* Positive pregnancy test, pregnancy or lactation.
* Undergoing an emergency operation.
* Proof or suspicion of a congenital or acquired coagulation disorder.
* Clopidogrel use in the 5 days preceding surgery.
* INR \>1.4 if on coumadin.
D: Inclusion Criteria:

* Emergency
* Trauma patient admitted in participating trauma care centers
* Severe bleeding requiring transfusion with 4 units of red blood cells and 4 emergency plasma.
* Inclusion performed within the first 6 hours after trauma.

Exclusion Criteria:

* Patient taking anticoagulants
* Patients who have received hemostatic treatment during transport (tranexamic -acid excluded)
* Minor Patient
* Pregnant or breastfeeding women

Answer: C