Cross Iron (Comparative Randomized Oral Versus Systemic IRON)

Comparison of Preoperative Haemoglobin Level After Administration of Epoetin Alfa Associated With an Oral Versus Intravenous Iron Supplementation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02496377

Acronym

Cross Iron

Enrollment

100

Registered

2015-07-14

Start date

2014-08-29

Completion date

2016-10-16

Last updated

2019-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allogenic Transfusion, Hip Arthroplasty, Knee Arthroplasty, Perioperative Anaemia

Keywords

Anaemia, Iron deficiency, Ferric carboxymaltose, Patient blood management, Hip arthroplasty, Knee arthroplasty

Brief 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. 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.

Interventions

DRUGferrous glycine sulfate Tardyferon

DRUGEpoetin Alfa

DRUGferric carboxymaltose Ferinject

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* unilateral prothetic orthopaedic surgery scheduled * age \> 18 * weight \> 50 kg * hemoglobin rate: 10 g/dl ≤ Hb \<13 g/dl

Exclusion criteria

* bilateral arthroplasty * EPO contraindication * generalized infection

Design outcomes

Primary

Measure	Time frame
Compare Hb level after treatment with EPO associated with iron treatment by oral or intravenous route	the day before surgery (day - 1)

Secondary

Measure	Time frame
Hb level	before iron treatment, then the day before surgery (day - 1) based on reference iron balance
number of red blood cells	during surgery and 3 days after surgery
the change in iron indices	before iron treatment and after iron treatment the day before surgery (day - 1)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026