Cross Iron (Comparative Randomized Oral Versus Systemic IRON)

Knee Arthroplasty Clinical Trial

— Cross Iron  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02496377
• Other study ID #: 9408
• Secondary ID: 2014-A00642-45
• Status: Completed
• Phase: N/A
• Start date: August 29, 2014
• Est. completion date: October 16, 2016

Study information

• Verified date: January 2019
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 16, 2016
• Est. primary completion date: October 16, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allogenic Transfusion
• Hip Arthroplasty
• Knee Arthroplasty
• Perioperative Anaemia

Intervention

Drug:
• ferrous glycine sulfate Tardyferon

• Epoetin Alfa

• ferric carboxymaltose Ferinject

Locations

Country	Name	City	State
France	Hôpital Lapeyronie - Département Anesthésie Réanimation A	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare Hb level after treatment with EPO associated with iron treatment by oral or intravenous route		the day before surgery (day - 1)
Secondary	Hb level		before iron treatment, then the day before surgery (day - 1) based on reference iron balance
Secondary	number of red blood cells		during surgery and 3 days after surgery
Secondary	the change in iron indices		before iron treatment and after iron treatment the day before surgery (day - 1)