Please select the eligibility criteria that correspond to the clinical trial below.
Title: HiFIT Study: Interest of Intravenous Iron and Tranexamic Acid to Reduce Transfusion in Hip Fracture Patients
Brief Summary: Fractures of the upper end of the femur, called commonly "Hip fractures" are very common, with an incidence of approximately 1.6 million cases per year worldwide. This high incidence is anticipated to grow rapidly in the next decades, driven by population aging. Anemia is very frequent on admission for hip fracture, concerning up to 45% of the patients, with a mean hemoglobin level of 12.5±0.2 g/dl. This high prevalence of anemia together with blood losses, secondary to the fracture itself and surgery are responsible for a high rate of blood transfusion (approximately 40-50% of the patients). However, both anemia and blood transfusion are associated with poor outcome, including increased mortality, length of stay, infection rate etc. In addition, blood is a scarce and expensive resource and its use should be limited as much as possible. There is therefore a need to treat this anemia and/or to prevent the decrease in hemoglobin. For this purpose, intravenous iron has been proposed. Some non-randomized, mainly retrospective, studies have shown that perioperative intravenous iron was able to reduce blood transfusion (i.e. the number of patients transfused and the number of units per patient). Another way to reduce blood transfusion would be to reduce perioperative bleeding. Tranexamic acid has proven to be efficient for this purpose both in trauma patients and in elective surgery patients.The interest for perioperative blood management has recently increased thanks to better recognition of the adverse effects of blood transfusion, better understanding of iron metabolism, new intravenous iron drugs and a renewed interest in former medications (i.e. tranexamic acid). HiFIT study therefore propose a 2X2 factorial design for this study in order to answer questions vis-à-vis the interest of iron and tranexamic acid to reduce blood transfusion in hip fracture patients.


Options:
A: Inclusion Criteria:

* Subjects \>= 18 years of age, requiring non-emergent, open, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures
* Presence of an appropriate soft tissue Target Bleeding Site (TBS) as identified intraoperatively by the surgeon
* Subjects must be willing to participate in the study, and provide written informed consent

Exclusion Criteria:

* Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure
* Subject with TBS within an actively infected field
* Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine
* Subjects with known intolerance to blood products or to one of the components of the study product
* Subjects unwilling to receive blood products
* Subjects with immunodeficiency diseases (including known HIV)
* Subjects who are known, current alcohol and / or drug abusers
* Subjects who have participated in another investigational drug or device research study within 30 days of enrollment
* Female subjects who are pregnant or nursing
B: Inclusion Criteria:

* Age ≥ 18 years,
* Osteoporotic Fractures of the upper end of the femur requiring surgical repair.
* Preoperative hemoglobin between 9.5 and 13 g/dl.
* Patient or relative signed informed consent or inclusion thanks to urgent inclusion procedure

Exclusion Criteria:

* Bone marrow disease or ongoing treatment (such as chemotherapy), which could interfere with bone marrow erythropoiesis,
* Known allergy or counter-indication to iron and/or to tranexamic acid,
* Uncontrolled arterial hypertension,
* Recent iron infusion (within one week),
* Blood transfusion within one week before inclusion or preoperative blood transfusion already scheduled,
* Any patient who cannot be transfused or has refused consent for a blood transfusion,
* Bedridden or very dependent patient (equivalent to GIR 1 or 2 class).
* Non-affiliation to French health care coverage,
* Adult patient protected under the law (guardianship),
* Pregnancy.
C: Inclusion Criteria:

All of the following criteria must be met to be eligible:

1. 18 years of age or older
2. Diagnosis of hip fracture (Intracapsular, Intratrochanteric or Subtrochanteric) requiring surgical repair
3. Patient/surrogate decision maker provide signed informed consent

Exclusion Criteria:

Participants cannot be included in this study if any of the following criteria apply:

1. Patient has documented renal failure with glomerular filtration rate of \<30ml/min/1.73m2
2. Documented allergy to tranexamic acid
3. Current use of hormone replacement therapy
4. Acquired disturbances of colour vision
5. Refusal of blood products
6. Pre-operative use of anticoagulant therapy (Coumadin, heparin \< 5 days of surgery, fibrinolytic disorders requiring intraoperative anti-fibrinolytic treatment)
7. Coagulopathy (pre-operative platelet count \<150,000/mm3, International Normalized Ratio (INR) \>1.4, prolonged Partial Thromboplastin Time (PTT) \>1.4x normal)
8. Hematuria
9. Acute coronary syndrome within 6 weeks of fracture
10. Any history of venous thromboembolism
11. Any intraoperative surgical/medical/anesthetic complications i.e.: myocardial infarction or neurovascular injury occurring prior to application of the tranexamic acid
12. Pregnant or lactating
13. Any major medical or psychiatric disorder that in the opinion of the investigator, might prevent the subject from completely participating in the study or interfere with the interpretation of the study results
14. Unable/unwilling to provide informed consent
D: Inclusion Criteria:

* Age \> 18 years.
* Scheduled for primary unilateral hip arthroplasty
* Able to give consent

Exclusion Criteria:

* Allergy towards adrenaline
* Current treatment with: ADP receptor inhibitors or Vitamin K antagonists (within 5 days), Factor Xa inhibitors or Thrombin inhibitors (within 1 day), heparin (excluding low molecular weight heparin for perioperative thromboprophylaxis).
* Current treatment with tricyclic antidepressants
* Use of MAO inhibitors (within previous 14 days) or COMT inhibitors (within 2 days).
* Acute coronary syndrome / myocardial infarction within the previous 6 months.
* not willing to accept blood transfusion
* Participation in other clinical trial within previous 30 days
* Women of childbearing age (without menopause for at least 12 months)
* Glaucoma
* Pheochromocytoma
* Low serum K+ (\< 3.0 mmol/L)
* Thyrotoxicosis
* Digoxin intoxication
* Alcohol og drug abuse (investigators judgement)

Answer: B