Cross Iron (Comparative Randomized Oral Versus Systemic IRON)

NCT ID: NCT02496377

Last Updated: 2019-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-29
• Study Completion Date: 2016-10-16

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.

Conditions

Allogenic Transfusion; Perioperative Anaemia; Knee Arthroplasty; Hip Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Group 1: Per Os Tardyferon

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).

Group Type: ACTIVE_COMPARATOR

ferrous glycine sulfate Tardyferon

Intervention Type: DRUG

Epoetin Alfa

Intervention Type: DRUG

Group 2: IV Ferinject

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.

Group Type: EXPERIMENTAL

Epoetin Alfa

Intervention Type: DRUG

ferric carboxymaltose Ferinject

Intervention Type: DRUG

Interventions

ferrous glycine sulfate Tardyferon

Intervention Type: DRUG

Epoetin Alfa

Intervention Type: DRUG

ferric carboxymaltose Ferinject

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe BIBOULET, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Montpellier University Hospital

Locations

Hôpital Lapeyronie - Département Anesthésie Réanimation A

Montpellier, , France

Countries

France

Other Identifiers

2014-A00642-45

Identifier Type: REGISTRY

Identifier Source: secondary_id

9408

Identifier Type: -

Identifier Source: org_study_id