Allogenic TransfusionCross IronNCT02496377
Cross Iron (Comparative Randomized Oral Versus Systemic IRON)
A study testing ferrous glycine sulfate Tardyferon, Epoetin Alfa and ferric carboxymaltose Ferinject in people with Allogenic Transfusion and Perioperative Anaemia, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Patients were recruited at the scheduled preoperative visit for hip or knee arthroplasty. If the haemoglobin (Hb) level was below 13 g/dl with no contraindication to iron supplementation the patients were randomized to the oral or intravenous (IV) group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allogenic Transfusion, Perioperative Anaemia, Knee Arthroplasty
- What is being tested?
- ferrous glycine sulfate Tardyferon, Epoetin Alfa and ferric carboxymaltose Ferinject
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 29 Aug 2014to 16 Oct 2016
- Phase
- Interventional
- 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
- unilateral prothetic orthopaedic surgery scheduled
- age > 18
- weight > 50 kg
- hemoglobin rate: 10 g/dl ≤ Hb <13 g/dl
Who cannot join
- bilateral arthroplasty
- EPO contraindication
- generalized infection
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Lapeyronie - Département Anesthésie Réanimation A
Montpellier, 34295
About this study
Official title: Comparison of Preoperative Haemoglobin Level After Administration of Epoetin Alfa Associated With an Oral Versus Intravenous Iron Supplementation
Patients were recruited at the scheduled preoperative visit for hip or knee arthroplasty. If the haemoglobin (Hb) level was below 13 g/dl with no contraindication to iron supplementation the patients were randomized to the oral or intravenous (IV) group. The oral group received 160 mg ferrous glycine sulfate daily during the month prior surgery, associated with 3 epoetin alpha (EPO) injections (40 000 IU subcutaneous on day - 21, day - 14 and day-7). The IV group received ferric carboxymaltose 1000 mg IV in 15 minutes one month before surgery, associated with 3 EPO injections. Primary efficacy endpoint was the change in Hb level from the day of the preoperative visit to the day before surgery (day-1). Secondary endpoints comprised the Hb level on day 3 and 5 after surgery, allogenic transfusion during and after surgery, and the change in iron indices from the day of the preoperative visit to day - 1.
- Being tested
- ferrous glycine sulfate Tardyferon, Epoetin Alfa, ferric carboxymaltose Ferinject
- Keywords
- Anaemia, Iron deficiency, Ferric carboxymaltose, Patient blood management, Hip arthroplasty, Knee arthroplasty
- Medical subject headings
- Anemia, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ferrous glycine sulfate TardyferonDrug
Epoetin AlfaDrug
ferric carboxymaltose FerinjectDrug
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Per Os Tardyferon | Active comparator | EPO associated with Iron per os tardyferon before surgery. The oral group received 160 mg ferrous glycine sulfate daily during the month prior surgery, associated with 3 epoetin alpha (EPO) injections (40 000 IU subcutaneous on day - 21, day - 14 and day-7). Receives: Drug: ferrous glycine sulfate Tardyferon; Drug: Epoetin Alfa |
| Group 2: IV Ferinject | Experimental | EPO associated with Iron per IV Ferinject before surgery. The IV group received ferric carboxymaltose 1000 mg IV in 15 minutes one month before surgery, associated with 3 EPO injections. Receives: Drug: Epoetin Alfa; Drug: ferric carboxymaltose Ferinject |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Hb level after treatment with EPO associated with iron treatment by oral or intravenous route
Measured: the day before surgery (day - 1)
Secondary outcomes (3)
Hb level
Measured: before iron treatment, then the day before surgery (day - 1) based on reference iron balance
number of red blood cells
Measured: during surgery and 3 days after surgery
the change in iron indices
Measured: before iron treatment and after iron treatment the day before surgery (day - 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study start29 Aug 2014
- Primary completion16 Oct 2016
- Study completion16 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogenic TransfusionStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe BIBOULET, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496377
- Sponsor's protocol ID
- 9408
- Other IDs
- 2014-A00642-45
- Acronym
- Cross Iron
- Status last verified
- Jan 2019
- First submitted
- 19 Jun 2015
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Preoperative Haemoglobin Level After Administration of Epoetin Alfa Associated With an Oral Versus Intravenous Iron Supplementation
- ClinicalTrials.gov ID
- NCT02496377
- Acronym / sponsor ID
- Cross Iron / 9408
- Keywords
- Anaemia, Iron deficiency, Ferric carboxymaltose, Patient blood management, Hip arthroplasty, Knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 29 Aug 2014 (actual)
- Primary completion
- 16 Oct 2016 (actual)
- Study completion
- 16 Oct 2016 (actual)
- First posted
- 14 Jul 2015 (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.
Patients were recruited at the scheduled preoperative visit for hip or knee arthroplasty. If the haemoglobin (Hb) level was below 13 g/dl with no contraindication to iron supplementation the patients were randomized to the oral or intravenous (IV) group. The oral group received 160 mg ferrous glycine sulfate daily during the month prior surgery, associated with 3 epoetin alpha (EPO) injections (40 000 IU subcutaneous on day - 21, day - 14 and day-7). The IV group received ferric carboxymaltose 1000 mg IV in 15 minutes one month before surgery, associated with 3 EPO injections. Primary efficacy endpoint was the change in Hb level from the day of the preoperative visit to the day before surgery (day-1). Secondary endpoints comprised the Hb level on day 3 and 5 after surgery, allogenic transfusion during and after surgery, and the change in iron indices from the day of the preoperative visit to day - 1.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Per Os Tardyferon | Active comparator | Drug: ferrous glycine sulfate Tardyferon, Drug: Epoetin AlfaEPO associated with Iron per os tardyferon before surgery. The oral group received 160 mg ferrous glycine sulfate daily during the month prior surgery, associated with 3 epoetin alpha (EPO) injections (40 000 IU subcutaneous on day - 21, day - 14 and day-7). |
| Group 2: IV Ferinject | Experimental | Drug: Epoetin Alfa, Drug: ferric carboxymaltose FerinjectEPO associated with Iron per IV Ferinject before surgery. The IV group received ferric carboxymaltose 1000 mg IV in 15 minutes one month before surgery, associated with 3 EPO injections. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- unilateral prothetic orthopaedic surgery scheduled
- age > 18
- weight > 50 kg
- hemoglobin rate: 10 g/dl ≤ Hb <13 g/dl
Key exclusion criteria (3 listed)
- bilateral arthroplasty
- EPO contraindication
- generalized infection
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 |
|---|---|---|
| ferrous glycine sulfate Tardyferon | Drug | Group 1: Per Os Tardyferon |
| Epoetin Alfa | Drug | Group 1: Per Os Tardyferon, Group 2: IV Ferinject |
| ferric carboxymaltose Ferinject | Drug | Group 2: IV Ferinject |
Primary outcome
Compare Hb level after treatment with EPO associated with iron treatment by oral or intravenous route
Time frame: the day before surgery (day - 1)
3 secondary outcomes
Hb level
Time frame: before iron treatment, then the day before surgery (day - 1) based on reference iron balance
number of red blood cells
Time frame: during surgery and 3 days after surgery
the change in iron indices
Time frame: before iron treatment and after iron treatment the day before surgery (day - 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
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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.
Philippe BIBOULET, MD, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ferrous glycine sulfate Tardyferon, Epoetin Alfa and ferric carboxymaltose Ferinject in people with Allogenic Transfusion and Perioperative Anaemia, run by University Hospital, Montpellier at 1 site 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 3 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: finished, as of the sponsor's last update on 23 Jan 2019. 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 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compare Hb level after treatment with EPO associated with iron treatment by oral or intravenous route (time frame: the day before surgery (day - 1)). 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 23 Jan 2019.