Please select the arm or intervention descriptions that belong 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: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Fibrin Pad | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Device: SURGICEL™ | Intervention Type: DRUG; Name: Fibrin Pad; Assigned to Arm(s): 1 | Intervention Type: DEVICE; Name: SURGICEL™; Assigned to Arm(s): 2
B: Arm Label: TXA + IIM; Type: EXPERIMENTAL; Interventions: Drug: Iron Isomaltoside 1000, Drug: Tranexamic Acid | Arm Label: Placebo TXA + IIM; Type: EXPERIMENTAL; Interventions: Drug: Iron Isomaltoside 1000, Drug: Placebos tranexamic acid | Arm Label: TXA + Placebo IIM; Type: EXPERIMENTAL; Interventions: Drug: Tranexamic Acid, Drug: Placebos iron isomaltoside 1000 | Arm Label: Placebo TXA + Placebo IIM; Type: EXPERIMENTAL; Interventions: Drug: Placebos iron isomaltoside 1000, Drug: Placebos tranexamic acid | Intervention Type: DRUG; Name: Iron Isomaltoside 1000; Assigned to Arm(s): Placebo TXA + IIM, TXA + IIM | Intervention Type: DRUG; Name: Tranexamic Acid; Assigned to Arm(s): TXA + IIM, TXA + Placebo IIM | Intervention Type: DRUG; Name: Placebos iron isomaltoside 1000; Assigned to Arm(s): Placebo TXA + Placebo IIM, TXA + Placebo IIM | Intervention Type: DRUG; Name: Placebos tranexamic acid; Assigned to Arm(s): Placebo TXA + IIM, Placebo TXA + Placebo IIM
C: Arm Label: Tranexamic Acid Wash; Type: EXPERIMENTAL; Interventions: Drug: Tranexamic Acid | Arm Label: Saline Wash; Type: PLACEBO_COMPARATOR; Interventions: Other: Saline Wash | Intervention Type: DRUG; Name: Tranexamic Acid; Assigned to Arm(s): Tranexamic Acid Wash | Intervention Type: OTHER; Name: Saline Wash; Assigned to Arm(s): Saline Wash
D: Arm Label: Adrenaline; Type: EXPERIMENTAL; Interventions: Drug: Adrenaline | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Adrenaline; Assigned to Arm(s): Adrenaline | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: B