Hip Fractures PathologicPhase 3HiFITNCT02972294
HiFIT Study : Hip Fracture: Iron and Tranexamic Acid
A Phase 3 study testing Iron Isomaltoside 1000 and Tranexamic Acid in people with Hip Fractures Pathologic and Anemia, run by University Hospital, Angers at 13 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures Pathologic, Anemia
- What is being tested?
- Iron Isomaltoside 1000 and Tranexamic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 419 participants
- Where
- 13 sitesFrance
- Study dates
- 31 Mar 2017to 16 Sep 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 10Show fewer
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
CHU Angers - DEPARTEMENT D'ANESTHESIE REANIMATION
Angers, 49000
Clinique de L'Anjou- Anesthesie Reanimation
Angers, 49000
HIA Clermont-Tonnerre
Brest
Chu Grenoble - Departement D'Anesthesie Reanimation
Grenoble, 38043
CHD Vendée
La Roche-sur-Yon
CHU Lille
Lille, 59037
Hospices Civils Lyon
Lyon, 69002
Ramsay Santé, Clinique de la Sauvegarde
Lyon
Chu Montpellier - Departement D'Anesthesie Reanimation
Montpellier, 34295
Chu Nantes- Service de Reanimation Chirurgicale
Nantes, 44093
Chu Poitiers - Service D'Anesthesie Reanimation
Poitiers, 86000
Chu Rennes - Service D'Anesthesie Reanimation
Rennes, 35033
Medipôle
Villeurbanne
About this study
Official title: HiFIT Study: Interest of Intravenous Iron and Tranexamic Acid to Reduce Transfusion in Hip Fracture Patients
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.
Read the detailed description
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). Indeed, a pooled analysis of 5 studies including 1,361 patients suggests that intravenous iron could reduce perioperative transfusion in hip fracture patients. However, there is no definitive data. 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. However, there are only two randomized studies investigating the interest of tranexamic acid in hip fractures, and they are not conclusive probably owing to a lack of power. In addition, use of intravenous tranexamic acid could be limited in this population of frail patients and topical use of tranexamic acid, notably to prevent the intraoperative bleeding, appear to be an accurate and sure alternative.
Although hip fracture is a very frequent pathology, with a high burden of care, few data are available that focus on the management of perioperative anemia in this context. 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
- Being tested
- Iron Isomaltoside 1000, Tranexamic Acid, Placebos iron isomaltoside 1000, Placebos tranexamic acid
- Keywords
- iron isomaltoside, tranexamic acid
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron Isomaltoside 1000Drug
Also called monofer
Iron Isomaltoside 1000 will be use. Blinding procedure will be put in place for the administration of the treatment
Tranexamic AcidDrug
Also called exacyl
Tranexamic acid will be use.
Placebos iron isomaltoside 1000Drug
Also called saline serum
placebo of Iron Isomaltoside 1000 correspond to a saline solution. Blinding procedure will be put in place for the administration of this treatment
Placebos tranexamic acidDrug
Also called saline serum
placebo of tranexamic acid correspond to a saline solution.
| Study group | Role | What they receive |
|---|---|---|
| TXA + IIM | Experimental | The patients randomized to this arm will have iron isomaltoside 1000 and tranexamic acid Receives: Drug: Iron Isomaltoside 1000; Drug: Tranexamic Acid |
| Placebo TXA + IIM | Experimental | The patients randomized to this arm will have iron isomaltoside 1000 and Placebos tranexamic acid Receives: Drug: Iron Isomaltoside 1000; Drug: Placebos tranexamic acid |
| TXA + Placebo IIM | Experimental | The patients randomized to this arm will have Placebos iron isomaltoside 1000 and tranexamic acid Receives: Drug: Tranexamic Acid; Drug: Placebos iron isomaltoside 1000 |
| Placebo TXA + Placebo IIM | Experimental | The patients randomized to this arm will have Placebos iron isomaltoside 1000 and Placebos tranexamic acid Receives: Drug: Placebos iron isomaltoside 1000; Drug: Placebos tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who received a blood transfusion during their hospital stay following surgery
Proportion of patients who received a blood transfusion during their hospital stay following surgery
Measured: From the day of surgery until hospital discharge (or until day 30 if patient is still hospitalized).
Secondary outcomes (15)
Proportion of patients who received a blood transfusion after surgery
Proportion of patients who received a blood transfusion during the month following surgery (including fresh frozen plasma and platelets)
Measured: From the day of surgery until Day 3, Day 7 and Day 30 post surgery.
Number of packed red blood cell units transfused per patient, as well as number of fresh frozen plasma and platelets units
Number of packed red blood cell units transfused per patient, as well as number of fresh frozen plasma and platelets units
Measured: Till postoperative Day3, first week posteratively,and till hospital discharge (or one month if patients still hospitalised)
Hemoglobin concentration
Hemoglobin concentration
Measured: At inclusion and on days 3, 7 (or hospital discharge if it happens first) and 30.
Proportion of patients with anemia (hemoglobin <12 g/dL in women and <13 g/dL in men)
Proportion of patients with anemia (hemoglobin <12 g/dL in women and <13 g/dL in men)
Measured: At inclusion and on days 3, 7, hospital discharge (if it happens before Day 30) and 30.
Reticulocytes count
Reticulocytes count
Measured: On days 3, 7 (or hospital discharge if it happens first) and 30 post surgery
Perioperative blood loss (estimated according to a formula based on hematocrit variation).
Perioperative blood loss (estimated according to a formula based on hematocrit variation): (HtD0 - HtD3)*TBV + number of RPBC transfused unit x 200 ml. Ht = Haematocrit, TBV = total blood volume (70 mL/kg in men and 65 mL/kg in women)
Measured: During surgery
Post operative Iron deficiency rate
Proportion of patients with Iron deficiency (defined as a ferritin < 100 ng/ml or < 300 ng/ml together with transferrin saturation <20%), measurement of ferritin and transferrin saturation
Measured: On Day 7 (or hospital discharge if it happens first) and Day 30.
Number of hospitalization days
Number of hospitalization days
Measured: On Day 30 and Day 90 following surgery.
Proportion of patients at home
Proportion of patients returned at home (or at their previous place of living)
Measured: On Day 30 and Day 90.
Proportion of patients able to walk a distance of ten feet without assistance
Proportion of patients able to walk a distance of ten feet without assistance
Measured: On Day 30 and Day 90
Variation of quality of life
Variation of EQ-5D score
Measured: From inclusion to Day 30 and Day 90
Variation of perceived quality of life
Variation of perceived quality of life with a single overall item from PQOL scale
Measured: From inclusion to Day 7 (or hospital discharge if it happens first) and Day 90.
Variation of IADL test
Variation of IADL test
Measured: From inclusion to Day 90.
Death rate from all causes
Death rate from all causes
Measured: From inclusion to Day 90
Rate of adverse events including the following clinical complications: Vascular events, Heart failure; Renal failure; Infectious complications; Anaphylactic reaction; Transfusion-related complications
Rate of adverse events including the following clinical complications: Vascular events, Heart failure; Renal failure; Infectious complications; Anaphylactic reaction; Transfusion-related complications
Measured: From inclusion to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study start31 Mar 2017
- Primary completion16 Sep 2021
- Study completion16 Sep 2021
Why it stopped: 1year inclusion hold due to PV new fact (Monofer hold for risk revaluation) DSMB Interim analysis : 1treatment with important transfusion risk reduction/inclusions issues (COVID)/sites change of practice if study continue=\>stop inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hip Fractures PathologicStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 419 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sigismond SL Lasocki, PU-PH, Study director, UNIVERSITE HOSPITAL, ANGERS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972294
- Sponsor's protocol ID
- 49RC16_0014
- Acronym
- HiFIT
- Status last verified
- Jul 2022
- First submitted
- 21 Nov 2016
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lasocki S, Capdevila X, Bijok B, Lahlou-Casulli M, Collange V, Grillot N, Loupec T, Rineau E, Leger M; HiFIT Investigators. Quality of life of patients with hip fracture was better during the COVID-19 period than before, an ancillary study from the HiFIT multicenter study. Front Public Health. 2024 Apr 16;12:1362240. doi: 10.3389/fpubh.2024.1362240. eCollection 2024.
PubMed 38689774Lasocki S, Capdevila X, Vielle B, Bijok B, Lahlou-Casulli M, Collange V, Grillot N, Danguy des Deserts M, Duchalais A, Delannoy B, Drugeon B, Bouzat P, David JS, Rony L, Loupec T, Leger M, Rineau E; HiFIT Investigators; SFAR research network. Ferric derisomaltose and tranexamic acid, combined or alone, for reducing blood transfusion in patients with hip fracture (the HiFIT trial): a multicentre, 2 x 2 factorial, randomised, double-blind, controlled trial. Lancet Haematol. 2023 Sep;10(9):e747-e755. doi: 10.1016/S2352-3026(23)00163-1. Epub 2023 Jul 28.
PubMed 37524101Lasocki S, Bruckert V, Campfort M, Leger M, Rineau E. Restrictive transfusion targets the heart now! Insight from the REALITY study. Anaesth Crit Care Pain Med. 2021 Apr;40(2):100854. doi: 10.1016/j.accpm.2021.100854. Epub 2021 Mar 27. No abstract available.
PubMed 33781988Lasocki S, Loupec T, Parot-Schinkel E, Vielle B, Danguy des Deserts M, Roquilly A, Lahlou-Casulli M, Collange V, Desebbe O, Duchalais A, Drugeon B, Bouzat P, Garrigue D, Mounet B, Hamard F, David JS, Leger M, Rineau E; HiFIT Study Group. Study protocol for a multicentre, 2x2 factorial, randomised, controlled trial evaluating the interest of intravenous iron and tranexamic acid to reduce blood transfusion in hip fracture patients (the HiFIT study). BMJ Open. 2021 Jan 17;11(1):e040273. doi: 10.1136/bmjopen-2020-040273.
PubMed 33455926
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HiFIT Study: Interest of Intravenous Iron and Tranexamic Acid to Reduce Transfusion in Hip Fracture Patients
- ClinicalTrials.gov ID
- NCT02972294
- Acronym / sponsor ID
- HiFIT / 49RC16_0014
- Conditions
- Hip Fractures Pathologic, Anemia
- Keywords
- iron isomaltoside, tranexamic acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 1year inclusion hold due to PV new fact (Monofer hold for risk revaluation) DSMB Interim analysis : 1treatment with important transfusion risk reduction/inclusions issues (COVID)/sites change of practice if study continue=\>stop inclusions
- Enrolment
- 419 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 16 Sep 2021 (actual)
- Study completion
- 16 Sep 2021 (actual)
- First posted
- 23 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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). Indeed, a pooled analysis of 5 studies including 1,361 patients suggests that intravenous iron could reduce perioperative transfusion in hip fracture patients. However, there is no definitive data. 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. However, there are only two randomized studies investigating the interest of tranexamic acid in hip fractures, and they are not conclusive probably owing to a lack of power. In addition, use of intravenous tranexamic acid could be limited in this population of frail patients and topical use of tranexamic acid, notably to prevent the intraoperative bleeding, appear to be an accurate and sure alternative.
Although hip fracture is a very frequent pathology, with a high burden of care, few data are available that focus on the management of perioperative anemia in this context. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TXA + IIM | Experimental | Drug: Iron Isomaltoside 1000, Drug: Tranexamic AcidThe patients randomized to this arm will have iron isomaltoside 1000 and tranexamic acid |
| Placebo TXA + IIM | Experimental | Drug: Iron Isomaltoside 1000, Drug: Placebos tranexamic acidThe patients randomized to this arm will have iron isomaltoside 1000 and Placebos tranexamic acid |
| TXA + Placebo IIM | Experimental | Drug: Tranexamic Acid, Drug: Placebos iron isomaltoside 1000The patients randomized to this arm will have Placebos iron isomaltoside 1000 and tranexamic acid |
| Placebo TXA + Placebo IIM | Experimental | Drug: Placebos iron isomaltoside 1000, Drug: Placebos tranexamic acidThe patients randomized to this arm will have Placebos iron isomaltoside 1000 and Placebos tranexamic acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron Isomaltoside 1000Also: monoferIron Isomaltoside 1000 will be use. Blinding procedure will be put in place for the administration of the treatment | Drug | Placebo TXA + IIM, TXA + IIM |
| Tranexamic AcidAlso: exacylTranexamic acid will be use. | Drug | TXA + IIM, TXA + Placebo IIM |
| Placebos iron isomaltoside 1000Also: saline serumplacebo of Iron Isomaltoside 1000 correspond to a saline solution. Blinding procedure will be put in place for the administration of this treatment | Drug | Placebo TXA + Placebo IIM, TXA + Placebo IIM |
| Placebos tranexamic acidAlso: saline serumplacebo of tranexamic acid correspond to a saline solution. | Drug | Placebo TXA + IIM, Placebo TXA + Placebo IIM |
Primary outcome
Proportion of patients who received a blood transfusion during their hospital stay following surgery
Time frame: From the day of surgery until hospital discharge (or until day 30 if patient is still hospitalized).
Proportion of patients who received a blood transfusion during their hospital stay following surgery
15 secondary outcomes
Proportion of patients who received a blood transfusion after surgery
Time frame: From the day of surgery until Day 3, Day 7 and Day 30 post surgery.
Number of packed red blood cell units transfused per patient, as well as number of fresh frozen plasma and platelets units
Time frame: Till postoperative Day3, first week posteratively,and till hospital discharge (or one month if patients still hospitalised)
Hemoglobin concentration
Time frame: At inclusion and on days 3, 7 (or hospital discharge if it happens first) and 30.
Proportion of patients with anemia (hemoglobin <12 g/dL in women and <13 g/dL in men)
Time frame: At inclusion and on days 3, 7, hospital discharge (if it happens before Day 30) and 30.
Reticulocytes count
Time frame: On days 3, 7 (or hospital discharge if it happens first) and 30 post surgery
Perioperative blood loss (estimated according to a formula based on hematocrit variation).
Time frame: During surgery
Post operative Iron deficiency rate
Time frame: On Day 7 (or hospital discharge if it happens first) and Day 30.
Number of hospitalization days
Time frame: On Day 30 and Day 90 following surgery.
Proportion of patients at home
Time frame: On Day 30 and Day 90.
Proportion of patients able to walk a distance of ten feet without assistance
Time frame: On Day 30 and Day 90
Variation of quality of life
Time frame: From inclusion to Day 30 and Day 90
Variation of perceived quality of life
Time frame: From inclusion to Day 7 (or hospital discharge if it happens first) and Day 90.
Variation of IADL test
Time frame: From inclusion to Day 90.
Death rate from all causes
Time frame: From inclusion to Day 90
Rate of adverse events including the following clinical complications: Vascular events, Heart failure; Renal failure; Infectious complications; Anaphylactic reaction; Transfusion-related complications
Time frame: From inclusion to Day 90
Results and safety
The study was stopped early (reason given: 1year inclusion hold due to PV new fact (Monofer hold for risk revaluation) DSMB Interim analysis : 1treatment with important transfusion risk reduction/inclusions issues (COVID)/sites change of practice if study continue=\>stop inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Derived from this study: PubMed 38689774Lasocki S, Capdevila X, Bijok B, Lahlou-Casulli M, Collange V, Grillot N, Loupec T, Rineau E, Leger M; HiFIT Investigators. Quality of life of patients with hip fracture was better during the COVID-19 period than before, an ancillary study from the HiFIT multicenter study. Front Public Health. 2024 Apr 16;12:1362240. doi: 10.3389/fpubh.2024.1362240. eCollection 2024.
- Derived from this study: PubMed 37524101Lasocki S, Capdevila X, Vielle B, Bijok B, Lahlou-Casulli M, Collange V, Grillot N, Danguy des Deserts M, Duchalais A, Delannoy B, Drugeon B, Bouzat P, David JS, Rony L, Loupec T, Leger M, Rineau E; HiFIT Investigators; SFAR research network. Ferric derisomaltose and tranexamic acid, combined or alone, for reducing blood transfusion in patients with hip fracture (the HiFIT trial): a multicentre, 2 x 2 factorial, randomised, double-blind, controlled trial. Lancet Haematol. 2023 Sep;10(9):e747-e755. doi: 10.1016/S2352-3026(23)00163-1. Epub 2023 Jul 28.
- Derived from this study: PubMed 33781988Lasocki S, Bruckert V, Campfort M, Leger M, Rineau E. Restrictive transfusion targets the heart now! Insight from the REALITY study. Anaesth Crit Care Pain Med. 2021 Apr;40(2):100854. doi: 10.1016/j.accpm.2021.100854. Epub 2021 Mar 27. No abstract available.
- Derived from this study: PubMed 33455926Lasocki S, Loupec T, Parot-Schinkel E, Vielle B, Danguy des Deserts M, Roquilly A, Lahlou-Casulli M, Collange V, Desebbe O, Duchalais A, Drugeon B, Bouzat P, Garrigue D, Mounet B, Hamard F, David JS, Leger M, Rineau E; HiFIT Study Group. Study protocol for a multicentre, 2x2 factorial, randomised, controlled trial evaluating the interest of intravenous iron and tranexamic acid to reduce blood transfusion in hip fracture patients (the HiFIT study). BMJ Open. 2021 Jan 17;11(1):e040273. doi: 10.1136/bmjopen-2020-040273.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sigismond SL Lasocki, PU-PH study director
UNIVERSITE HOSPITAL, ANGERS
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Iron Isomaltoside 1000 and Tranexamic Acid in people with Hip Fractures Pathologic and Anemia, run by University Hospital, Angers at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 1year inclusion hold due to PV new fact (Monofer hold for risk revaluation) DSMB Interim analysis : 1treatment with important transfusion risk reduction/inclusions issues (COVID)/sites change of practice if study continue=\>stop inclusions). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who received a blood transfusion during their hospital stay following surgery (time frame: From the day of surgery until hospital discharge (or until day 30 if patient is still hospitalized).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02972294, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.