Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multi-Centre, Randomised, Double-Blind, Placebo Controlled Trial on Efficacy and Safety of FXIII Replenishment With Two Different Doses of Recombinant Factor XIII Following Cardiopulmonary Bypass Surgery
Brief Summary: This trial is conducted in Canada, Asia, Europe and USA. The aim of this clinical trial is to investigate the effect and safety of rFXIII on transfusion needs in patients undergoing heart surgery.


Options:
A: Inclusion Criteria:

* Eighteen years of age or older
* Undergoing elective thoracoabdominal aortic replacement surgery (TAAA) or thoracic aortic replacement surgery (TAA)
* Understood and willingly given written informed consent (German language) to participate following an explanation of study background, restrictions, and procedures
* Experience clinically relevant bleeding of the microvasculature following removal of CPB during surgery

Exclusion Criteria:

* Positive pregnancy test, pregnancy or lactation
* Women of child bearing age not using a medically approved method of contraception during the study
* Previous aortic replacement at the same aortic site (redo surgeries)
* Undergoing an emergency operation
* Proof or suspicion of a congenital or acquired coagulation disorder (e.g. VWD or via severe liver disease)
* Myocardial Infarction (MI) or apoplexy in the 2 months preceding study surgery
* ASA administration in the 3 days preceding study surgery, and a pathological (\<74.5 U) ASPI Multiplate® test immediately preceding surgery begin
* Clopidogrel administration in the 5 days preceding study surgery, and a pathological (\<31.1 U) ADP/PG Multiplate® test immediately preceding surgery begin
* Tirofiban administration in the 2 days preceding study surgery, and a pathological (\<94.1 U) TRAP Multiplate® test immediately preceding surgery begin
* Phenprocoumon administration in the 5 days preceding study surgery, and an INR \> 1.28 immediately preceding surgery begin
* Participation in another clinical study in the 4 weeks preceding aortic replacement
* Sensitivity to any of the components of study medication, or to MPs with a similar chemical structure to any of the components of study medication
* Any indication that the restrictions or procedures of the study may not be adhered to (e.g. an uncooperative attitude)
* Any indication that the study restrictions, procedures, or consequences therein have not been considered or understood, such that informed consent cannot be convincingly given
* Multiple morbidities, with a notably constrained remaining length of life
B: Inclusion Criteria:

* Males and Females
* Age 6 months to 17 years
* Scheduled for elective scoliosis surgery or major craniofacial surgery
* Written informed consent has been obtained
* Intraoperative hypofibrinogenemia according to definition of treatment groups

Exclusion Criteria:

* Preexisting congenital or acquired coagulation disorder
* Medical history of estimated increased bleeding tendency
* Ongoing coagulation therapy
* Clinical signs or diagnosis of acute thromboembolism
* Intolerance of study drug
* Participation at another clinical trial
* Pregnant or lactating women
C: Inclusion Criteria:

* - Planned coronary artery bypass grafting (CABG) or CABG plus single heart valve replacement/repair or planned replacement/repair of a single heart valve

Exclusion Criteria:

* Known intolerance to protamine
* Known or suspected allergy to the used antifibrinolytic agent
* Refusal to receive blood or blood product
* Planned surgery including the aortic arch and/or descending aorta
* Planned surgery including any implantable ventricular assist device
* Adult congenital heart diseases
* Two or more previous cardiac surgery procedures
* Any known autoimmune diseases: Collagen vascular disease (Systemic lupus erythematosus, Rheumatoid arthritis, Sjögrens syndrome) - Endocrine: hyperthyroidism (Graves disease), adrenal insufficiency, Hashimoto's thyroiditis - Neurologic: Multiple sclerosis, myasthenia gravis - Skin: pemphigous vulgaris Hematologic: Pernicious anaemia, Autoimmune haemolytic anaemia - Vasculitis - Primary or secondary antiphospholipid syndrome
* Weight above 140 kg
D: 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.

Answer: C