HiFIT Study : Hip Fracture: Iron and Tranexamic Acid

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.

Conditions

• Hip Fractures Pathologic
• Anemia

Interventions

DRUG

Iron Isomaltoside 1000

Iron Isomaltoside 1000 will be use. Blinding procedure will be put in place for the administration of the treatment

DRUG

Tranexamic Acid

Tranexamic acid will be use.

DRUG

Placebos iron isomaltoside 1000

placebo of Iron Isomaltoside 1000 correspond to a saline solution. Blinding procedure will be put in place for the administration of this treatment

DRUG

Placebos tranexamic acid

placebo of tranexamic acid correspond to a saline solution.

Sponsors & Collaborators

• University Hospital, Angers

  lead OTHER_GOV

Principal Investigators

• Sigismond SL Lasocki, PU-PH · UNIVERSITE HOSPITAL, ANGERS

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-03-31

Primary Completion

2021-09-16

Completion

2021-09-16

Countries

• France

Study Locations