Hip FracturePhase 4NCT01084122
Efficacy and Safety of Intravenous Iron Sucrose in Patients With Hip Fracture to Prevent Perioperative Anemia
A Phase 4 study testing Iron sucrose in people with Hip Fracture and Surgical Intervention, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of intravenous iron sucrose in patients with hip fracture and surgical intervention to prevent perioperative anemia. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fracture, Surgical Intervention
- What is being tested?
- Iron sucrose
- How many people
- 360 participants
- Where
- 1 siteSpain
- Study dates
- May 2010to Dec 2012
- 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
- Age >= 65 years old
- With Hip fracture or peritrochanteric fracture.
- Who needs surgical intervention.
- And sign the informed consent form.
Who cannot join
- Tumor pathological fracture.
- Two or more long bone fractures.
- Seric Ferritin levels > 300 ng/ml.
- Hypersensitivity to Iron sucrose or any component of the formulation.
- Patients with allogeneic transfusion rejection.
- Patients with previous blood transfusion request (Hb< 8g/dl).
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- Patients treated with hematopoietic growth factors.
- Patients with Anticoagulant treatment, due to thromboembolic high risk disease.
- Asthma in treatment.
- Cirrhosis, Acute Hepatitis, or increased Aminotransferases (> 3 times the upper limit of normal).
- Advanced Dementia (GDS>5) from the Global Deterioration Scale.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Servicio de Cirugía Ortopédica y Traumatología. Hospital Clinic.
Barcelona, Barcelona, 08036
Anna Domingo, MD, 932275533, adomingo@clinic.ub.es
About this study
The purpose of this study is to evaluate the safety and efficacy of intravenous iron sucrose in patients with hip fracture and surgical intervention to prevent perioperative anemia.
Read the detailed description
The main objective of this study is to evaluate the safety and efficacy of intravenous iron sucrose in patients with hip fracture and surgical intervention to prevent perioperative anemia.
It will also determine whether intravenous iron sucrose administration improve outcomes as Haemoglobin values, transfusional needs, postoperative complications, length of hospital stay and cost-effectiveness.
- Conditions
- Hip Fracture, Surgical Intervention
- Being tested
- Iron sucrose
- Keywords
- Intravenous iron sucrose, Anemia, Transfusion
- Medical subject headings
- Hip Fractures, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron sucroseDrug
Iron sucrose FERIV® (20 mg/ml). Dilution: 10 ml in 100 ml SF 0.9%. 25 ml in 15 minutes and the rest in others 15 minutes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfusional needs
Blood transfusion rate in patients over 65 years undergone hip fracture and surgical intervention.
Measured: 1st, 5th day and 1st and 6 th month after surgical intervention.
Secondary outcomes (2)
Units of packed cells
Packed cells average.
Measured: 1st and 5th days, 1st and 6th month after surgical intervention.
Postoperative complications
Infections, adverse reactions.
Measured: 1st and 5th day , 1st and 6th month after surgical intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084122
- Sponsor's protocol ID
- FEIV-DC-09
- Status last verified
- Jan 2010
- First submitted
- 9 Mar 2010
- Last updated
- 10 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Intravenous Iron Sucrose in Patients With Hip Fracture to Prevent Perioperative Anemia
- ClinicalTrials.gov ID
- NCT01084122
- Acronym / sponsor ID
- FEIV-DC-09
- Conditions
- Hip Fracture, Surgical Intervention
- Keywords
- Intravenous iron sucrose, Anemia, Transfusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2012 (estimated)
- First posted
- 10 Mar 2010 (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.
The purpose of this study is to evaluate the safety and efficacy of intravenous iron sucrose in patients with hip fracture and surgical intervention to prevent perioperative anemia.
Detailed description
The main objective of this study is to evaluate the safety and efficacy of intravenous iron sucrose in patients with hip fracture and surgical intervention to prevent perioperative anemia.
It will also determine whether intravenous iron sucrose administration improve outcomes as Haemoglobin values, transfusional needs, postoperative complications, length of hospital stay and cost-effectiveness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age >= 65 years old
- With Hip fracture or peritrochanteric fracture.
- Who needs surgical intervention.
- And sign the informed consent form.
Key exclusion criteria (11 listed)
- Tumor pathological fracture.
- Two or more long bone fractures.
- Seric Ferritin levels > 300 ng/ml.
- Hypersensitivity to Iron sucrose or any component of the formulation.
- Patients with allogeneic transfusion rejection.
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 sucroseIron sucrose FERIV® (20 mg/ml). Dilution: 10 ml in 100 ml SF 0.9%. 25 ml in 15 minutes and the rest in others 15 minutes. | Drug | – |
Primary outcome
Transfusional needs
Time frame: 1st, 5th day and 1st and 6 th month after surgical intervention.
Blood transfusion rate in patients over 65 years undergone hip fracture and surgical intervention.
2 secondary outcomes
Units of packed cells
Time frame: 1st and 5th days, 1st and 6th month after surgical intervention.
Postoperative complications
Time frame: 1st and 5th day , 1st and 6th month after surgical intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2010.
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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 in people with Hip Fracture and Surgical Intervention, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 11 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 10 Mar 2010. 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 Spain. 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?
Contact Anna Cruceta, MD (932279838, acruceta@clinic.ub.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transfusional needs (time frame: 1st, 5th day and 1st and 6 th month after surgical intervention.). 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 10 Mar 2010.