Hip FracturesPhase 4NCT05489952
Iron Supplementation for Geriatric Hip Fractures
A Phase 4 study testing iron sucrose and ferrous lactate in people with Hip Fractures and Fragility Fracture, run by He Qifei at 1 site in China.
Trial summary
Geriatric hip fracture is an important disease that affects the health life of the elderly in China. Geriatric hip fracture is often complicated by a variety of comorbidities due to advanced age. And anemia is a common comorbidity. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures, Fragility Fracture, Osteoporotic Fractures
- What is being tested?
- iron sucrose and ferrous lactate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 444 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2022to 15 Aug 2025
- Phase
- Phase 4
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- >65 years old patients with hip fracture
- Patients with iron deficiency or anemia,
- preoperative hemoglobin <13g/ dL in males and <12g/ dL in females, and >9g/ dL,
- serum ferritin < 100 ng/ mL or serum ferritin 100-299 ng/ mL or transferrin saturation (TSAT) <20%
Who cannot join
- Coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, and cardiac device implantation (including cardiac resynchronization) within preoperative 30 days
- Acute coronary syndrome, transient ischemic attack or stroke occurred within 30 days before surgery;
- Refused to sign the consent form to be included in the clinical trial group;
- Can't walk before injury;
- Use erythropoietic preparation within 3 months before surgery and oral iron preparation within 4 weeks 30 days before surgery(> 100 mg/ day)
- Patients with liver and kidney dysfunction
- Other conditions that the researchers considered inappropriate for inclusion
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shenzhen Second People's Hospita
Shenzhen, Guangdong, 518035
Chiephy He, Dr, 8615201278036, dr_chiephy@hsc.pku.edu.cn
About this study
Official title: Efficacy and Safety of Perioperative Iron Supplementation for Postoperative Rehabilitation of Geriatric Hip Fractures: a Multicenter, Randomized, Controlled Trial.
Geriatric hip fracture is an important disease that affects the health life of the elderly in China. Geriatric hip fracture is often complicated by a variety of comorbidities due to advanced age. And anemia is a common comorbidity. At present perioperative management of geriatric hip fracture, transfusion is only indicated for moderate and severe anemia, while no special medical intervention for mild anemia in China. More and more studies have found that iron can not only correct anemia, but also improve cardiac function, patients' quality of life and function. This study investigated the effect of perioperative iron supplementation on activity tolerance in elderly patients with hip fracture complicated with iron deficiency anemia. The study was a randomized, parallel controlled clinical study. Due to the requirements of the ethics committee, the unblinded setting was cancelled due to ethical considerations. Research will be grouped according to whether to accept iron supplementation treatment, are divided into 2 groups, respectively, iron treatment group and the traditional method. The method of randomization was stratified block randomization. The experimental group added to the intravenous iron sucrose during perioperative period according to the degree of iron deficiency. If there is still a iron deficiency or anemia at discharge, oral ferrous lactate is added after discharge. The outcomes include 6-minute walk distance, Harris score, EQ-5D score six months after surgery, perioperative blood transfusion rate, and so on in the two groups.
- Conditions
- Hip Fractures, Fragility Fracture, Osteoporotic Fractures
- Being tested
- iron sucrose and ferrous lactate
- Medical subject headings
- Hip Fractures, Osteoporotic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iron sucrose and ferrous lactateDrug
Also called iron supplementation
The experimental group added to the intravenous iron sucrose during perioperative period according to the degree of iron deficiency. If there is still a iron deficiency or anemia at discharge, oral ferrous lactate is added after discharge.
| Study group | Role | What they receive |
|---|---|---|
| iron supplement group | Experimental | Not described Receives: Drug: iron sucrose and ferrous lactate |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk distance
The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise. The 6 MWT provides information regarding functional capacity, response to therapy and prognosis across a broad range of chronic cardiopulmonary conditions.
Measured: 6 months
Secondary outcomes (2)
Harris hip score
The Harris Hip Scale (HHS) was developed for the assessment of the results of hip surgery, and is intended to evaluate various hip disabilities and methods of treatment in an adult population.
Measured: 6 months
perioperative blood transfusion rate
The proportion of the transfusions number to the total number of patients
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start15 Sep 2022 (estimated)
- Primary completion15 Feb 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 444 participants (estimated)
Sponsor and investigators
- Lead sponsor
- He Qifei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, He Qifei, Shenzhen Second People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489952
- Sponsor's protocol ID
- 20223357010
- Status last verified
- Sep 2022
- First submitted
- 31 Jul 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Perioperative Iron Supplementation for Postoperative Rehabilitation of Geriatric Hip Fractures: a Multicenter, Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT05489952
- Acronym / sponsor ID
- 20223357010
- Conditions
- Hip Fractures, Fragility Fracture, Osteoporotic Fractures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 444 participants (estimated)
- Lead sponsor
- He QifeiUniversity, hospital or other
- Study start
- 15 Sep 2022 (estimated)
- Primary completion
- 15 Feb 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 5 Aug 2022 (actual)
- 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.
Geriatric hip fracture is an important disease that affects the health life of the elderly in China. Geriatric hip fracture is often complicated by a variety of comorbidities due to advanced age. And anemia is a common comorbidity. At present perioperative management of geriatric hip fracture, transfusion is only indicated for moderate and severe anemia, while no special medical intervention for mild anemia in China. More and more studies have found that iron can not only correct anemia, but also improve cardiac function, patients' quality of life and function. This study investigated the effect of perioperative iron supplementation on activity tolerance in elderly patients with hip fracture complicated with iron deficiency anemia. The study was a randomized, parallel controlled clinical study. Due to the requirements of the ethics committee, the unblinded setting was cancelled due to ethical considerations. Research will be grouped according to whether to accept iron supplementation treatment, are divided into 2 groups, respectively, iron treatment group and the traditional method. The method of randomization was stratified block randomization. The experimental group added to the intravenous iron sucrose during perioperative period according to the degree of iron deficiency. If there is still a iron deficiency or anemia at discharge, oral ferrous lactate is added after discharge. The outcomes include 6-minute walk distance, Harris score, EQ-5D score six months after surgery, perioperative blood transfusion rate, and so on in the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iron supplement group | Experimental | Drug: iron sucrose and ferrous lactate |
| control group | No intervention | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- >65 years old patients with hip fracture
- Patients with iron deficiency or anemia,
Key exclusion criteria (7 listed)
- Coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, and cardiac device implantation (including cardiac resynchronization) within preoperative 30 days
- Acute coronary syndrome, transient ischemic attack or stroke occurred within 30 days before surgery;
- Refused to sign the consent form to be included in the clinical trial group;
- Can't walk before injury;
- Use erythropoietic preparation within 3 months before surgery and oral iron preparation within 4 weeks 30 days before surgery(> 100 mg/ day)
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 sucrose and ferrous lactateAlso: iron supplementationThe experimental group added to the intravenous iron sucrose during perioperative period according to the degree of iron deficiency. If there is still a iron deficiency or anemia at discharge, oral ferrous lactate is added after discharge. | Drug | iron supplement group |
Primary outcome
6-minute walk distance
Time frame: 6 months
The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise. The 6 MWT provides information regarding functional capacity, response to therapy and prognosis across a broad range of chronic cardiopulmonary conditions.
2 secondary outcomes
Harris hip score
Time frame: 6 months
perioperative blood transfusion rate
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing iron sucrose and ferrous lactate in people with Hip Fractures and Fragility Fracture, run by He Qifei at 1 site in China.
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 7 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: status not confirmed, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk distance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2022.