search
Back to results

Cross Iron (Comparative Randomized Oral Versus Systemic IRON) (Cross Iron)

Primary Purpose

Allogenic Transfusion, Perioperative Anaemia, Knee Arthroplasty

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ferrous glycine sulfate Tardyferon
Epoetin Alfa
ferric carboxymaltose Ferinject
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Allogenic Transfusion focused on measuring Anaemia, Iron deficiency, Ferric carboxymaltose, Patient blood management, Hip arthroplasty, Knee arthroplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hôpital Lapeyronie - Département Anesthésie Réanimation A

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group 1: Per Os Tardyferon

Group 2: IV Ferinject

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Compare Hb level after treatment with EPO associated with iron treatment by oral or intravenous route

Secondary Outcome Measures

Hb level
number of red blood cells
the change in iron indices

Full Information

First Posted
June 19, 2015
Last Updated
January 21, 2019
Sponsor
University Hospital, Montpellier
search

1. Study Identification

Unique Protocol Identification Number
NCT02496377
Brief Title
Cross Iron (Comparative Randomized Oral Versus Systemic IRON)
Acronym
Cross Iron
Official Title
Comparison of Preoperative Haemoglobin Level After Administration of Epoetin Alfa Associated With an Oral Versus Intravenous Iron Supplementation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 29, 2014 (Actual)
Primary Completion Date
October 16, 2016 (Actual)
Study Completion Date
October 16, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allogenic Transfusion, Perioperative Anaemia, Knee Arthroplasty, Hip Arthroplasty
Keywords
Anaemia, Iron deficiency, Ferric carboxymaltose, Patient blood management, Hip arthroplasty, Knee arthroplasty

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Per Os Tardyferon
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Group 2: IV Ferinject
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ferrous glycine sulfate Tardyferon
Intervention Type
Drug
Intervention Name(s)
Epoetin Alfa
Intervention Type
Drug
Intervention Name(s)
ferric carboxymaltose Ferinject
Primary Outcome Measure Information:
Title
Compare Hb level after treatment with EPO associated with iron treatment by oral or intravenous route
Time Frame
the day before surgery (day - 1)
Secondary Outcome Measure Information:
Title
Hb level
Time Frame
before iron treatment, then the day before surgery (day - 1) based on reference iron balance
Title
number of red blood cells
Time Frame
during surgery and 3 days after surgery
Title
the change in iron indices
Time Frame
before iron treatment and after iron treatment the day before surgery (day - 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe BIBOULET, MD, PhD
Organizational Affiliation
Montpellier University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Lapeyronie - Département Anesthésie Réanimation A
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Learn more about this trial

Cross Iron (Comparative Randomized Oral Versus Systemic IRON)

We'll reach out to this number within 24 hrs