Condition category
Surgery
Date applied
30/11/2012
Date assigned
23/04/2013
Last edited
18/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

Trial website

Contact information

Type

Scientific

Primary contact

Dr A.W.M.M. Koopman-van Gemert

ORCID ID

Contact details

Albert Schweitzerplaats 25
Dordrecht
3300AK
Netherlands
+31 (0)78 6541111
gemertvanaw@asz.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NL35394.101.11

Study information

Scientific title

Pre-OPerative Iron used as blood sparing technique in Orthopedic Surgery (total hip replacement and total knee replacement surgery, elective and no revision surgery): a three-arm randomised controlled trial

Acronym

POP-i

Study hypothesis

Can intravenous (i.v.) iron therapy can become a method of blood saving therapy for orthopedic surgery and can it replace erythropoietin?

Ethics approval

CCMO Maastad Hospital Rotterdam, Is an official ethics committee. nr. NL 35394.101.11. METCnr 2011_18
Letter METC of 3-10-2012. decision was made in their meeting on 26/09/2012

Study design

Three-arm randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Orthopedic surgery

Intervention

Three-arm randomised study in patients with a start Hb level > 6,1 and < = 8,1 mmol/l. Intervention groups will be compared with a control group.

The intervention group will receive i.v. iron infusion or Epo.
The control group will receive no intervention.

Both groups will be transfused following the Dutch Transfusion Guideline (4,5,6, Flexinorm).

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Can ferric carboxymaltose effectively reduce RBC transfusion rate compared to controls in elective orthopedic surgery patients?
2. Rate of transfused patients

Secondary outcome measures

1. Does i.v. iron therapy increase preoperative Hb-levels and improve postoperative recovery?
2. Is this i.v. iron therapy also efficient for patients with anemia other than iron deficiency (ACD)?
3. Is infusion of i.v. iron policlinically safe?
4. Cost reductions caused by introduction of i.v. iron therapy - can it then replace Epo?
5. Hospital stay
6. Postoperative complications
7. Time needed for revalidation
8. Measurement of quality of life
9. Total cost treatment
10. Hb-levels pre- and postoperatively
11. Amount of RBC per patient
12. Safety of IV iron

Overall trial start date

01/01/2013

Overall trial end date

01/01/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Orthopedic patients > 18 years , either sex, planned for primary total hip and total knee replacement operations with an preoperative > 6.1 mmol/l is > 7 gr/l and < 8.2 mmol/l is < 13.2 gr/

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1012

Participant exclusion criteria

1. Revision operations, preop Hb <= 6,1 mmol/l or > 8,2 mmol/l
2. All patients who wish not to receive blood transfusions
3. Uncontrolled hypertension (Diastolic blood pressure > 95 mm Hg)
4. Patients planned for preoperative autologous donation, cell salvage, wound reinfusion
5. Severe cardiac compromised patients, uncontrolled hypertension, severe disease peripheral arteries, arteria carotis or arteria cerebralis
6. Recent myocardial infarction of CVA or instable angina pectoris or heart failure
7. Prone for thrombosis (f.i. Factor V Leiden)
8. All patients with Hb-globinopathy such as sickle cell anemia or thalassemia
9. Patients with oncological processes except curred malignancy or skin cancer
10. Pregnancy, patients with ciclosporin therapy
11. Impossible to give prophylactic anticoagulant
12. Allergy to Epo or i.v. iron or additives
13 Infected wound, infected prothesis, infectious process at the moment of inclusion
14. Epileptic, chronic kidney and liver insufficiency
15. Iron diseases

Recruitment start date

01/01/2013

Recruitment end date

01/01/2015

Locations

Countries of recruitment

Netherlands

Trial participating centre

Albert Schweitzerplaats 25
Dordrecht
3300AK
Netherlands

Sponsor information

Organisation

Albert Schweitzer Hospital (Netherlands)

Sponsor details

Albert Schweitzerplaats 25
Dordecht
3311 AT
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.asz.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Albert Schweitzer Hospital (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes