Hip fracture
Conditions
Interventions
Trade Name: MONOFER 1000mg-10mL
Product Name: MONOFER
Pharmaceutical Form: Solution for injection
INN or Proposed INN: MONOFER
CAS Number: 9004-66-04
Other descriptive name: IRON(III) ISOMALTOSIDE 100
Sponsors
UHangers
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age = 18 years, - Osteoporotic hip fracture requiring surgical repair. - Preoperative hemoglobin between 9.5 and 13 g/dl. - Patient or relative signed informed consent or operating procedure for emergency inclusion Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 780 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 780
Exclusion criteria
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 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, - Non-affiliation to French health care coverage, - Adult patient protected under the law (guardianship), - Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Proportion of patients who received a blood transfusion during their hospital stay following surgery (from the day of surgery until hospital discharge (or until D30 if patient is still hospitalized).;Secondary Objective: Efficacy objectives : To evaluate the effect of these treatments on 1) The number of transfused units, 2) Postoperative hemoglobin levels and the anemia rate, 3) Perioperative bleeding, 4) Postoperative iron deficiency and ferritin levels, 5) Postoperative reeducation on day 30 and day 90 following surgery, (including the number of hospitalization days, the proportion of patients at home, the proportion of patients able to walk a distance of ten feet without assistance). 6) Quality of life and dependencies of patients for daily life activities. Safety objectives : 7) To evaluate the safety of these treatments. This objectives will be realized only by voluntary centers 8) To assess the effect if the treatment of postoperative anemia and / or the treatment of iron deficiency improve postoperative functional reeducation of patients on day 7 or hospital discharge if it happens first, (including the muscular strength and muscular fatigability, the locomotion and balance);Primary end point(s): Proportion of patients who received a blood transfusion during their hospital stay following surgery (from the day of surgery until hospital discharge (or until D30 if patient is still hospitalized).;Timepoint(s) of evaluation of this end point: from the day of surgery until hospital discharge (or until D30 if patient is still hospitalized) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy endpoints - Number of packed red blood cell units transfused per patient, as well as number of fresh frozen plasma and platelets units, during first week, hospital stay and till one month following surgery. - Hemoglobin concentration and proportion of patients with anemia (hemoglobin <12 g/dL in women and <13 g/dL in men) on days 3, 7 (or hospital discharge if it happens first) and 30. - Reticulocytes count on days 7 (or hospital discharge if it happens first) and 30. - Perioperative blood loss (estimated according to a formula based on hematocrit variation). - Iron deficiency (defined as a ferritin < 100 ng/ml or < 300 ng/ml together with transferrin saturation <20%), ferritin and transferrin saturation on D7 (or hospital discharge if it happens first) and D30. - Number of hospitalization days on D30 and D90 following surgery. - Proportion of patients at home on D30 and D90. - Proportion of patients able to walk a distance of ten feet without assistance on D30 and D90 - Variation of EuroQOL-5 Dimensions score from inclusion to D30 and D90 - Variation of perceived quality of life with a single overall item fro m PQOL scale from inclusion to D7 (or hospital discharge if it happens first) and D90. - Variation of Instrumental Activities of Daily Living test (IADL) from inclusion to D90. Safety endpoints: - Death rate from all causes on D90 - Rate of adverse events in the month following surgery including the following clinical complications: ? Vascular events (all kinds of cerebrovascular accidents, acute coronary syndrome, venous thrombosis, arterial embolism); ? Heart failure; ? Renal failure; ? Infectious complications (pneumonia, urinary tract infection, surgical site infection, bloodstream infection…); ? Anaphylactic reaction This outcomes measures will be collected only by voluntary centers - Maximum strength of the hand and forearm muscles assessed by the Hand Grip Strength test - Muscular fatigability between the first attempt a | — |
Countries
France
Contacts
Public ContactMaison de la Recherche
UHAngers
Outcome results
None listed