HiFIT Study : Hip Fracture: Iron and Tranexamic Acid
Status:
Active, not recruiting
Trial end date:
2021-10-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
University Hospital, Angers
Treatments:
Ferric Compounds Iron Iron isomaltoside 1000 Tranexamic Acid