Pre-operative Iron used as blood sparing technique in orthopedic surgery (total hip replacement and total knee replacement surgery, elective and no revision surgery)
| ISRCTN | ISRCTN75321849 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75321849 |
| Secondary identifying numbers | NL35394.101.11 |
- Submission date
- 30/11/2012
- Registration date
- 23/04/2013
- Last edited
- 29/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English Summary
Background and study aims
Patients with anemia (low blood hemoglobin) undergoing orthopedic surgery (e.g. hip or knee replacement) require more blood transfusions. In the Netherlands 70% of hospitals give erythropoietin treatment to this group of patients, but this treatment is expensive. The aim of this study is to find out whether intravenous iron treatment can replace erythropoietin and achieve the same results with lower costs.
Who can participate?
Patients aged over 18 with anemia (low blood hemoglobin) undergoing hip or knee replacements
What does the study involve?
Participants are randomly allocated to be treated with either intravenous iron infusion, erythropoietin, or no intervention (control group). The blood transfusion rates of the three groups are compared.
What are the possible benefits and risks of participating?
Participants may benefit from fewer blood transfusions and a better outcome because of higher hemoglobin levels. Besides very rare side effects of erythropoietin and iron infusions no major risks are expected.
Where is the study run from?
Albert Schweitzer Hospital (Netherlands)
When is the study starting and how long is it expected to run for?
January 2013 to January 2015
Who is funding the study?
Albert Schweitzer Hospital (Netherlands)
Who is the main contact?
Dr A.W.M.M. Koopman-van Gemert
gemertvanaw@asz.nl
Contact information
Scientific
Albert Schweitzerplaats 25
Dordrecht
3300AK
Netherlands
| Phone | +31 (0)78 6541111 |
|---|---|
| gemertvanaw@asz.nl |
Study information
| Study design | Three-arm randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study 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(s) | CCMO Maastad Hospital Rotterdam, Is an official ethics committee, 26/09/2012, nr. NL 35394.101.11. METCnr 2011_18 |
| 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 |
| Primary outcome measure | 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 study start date | 01/01/2013 |
| Overall study end date | 01/01/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1012 |
| 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/l |
| 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
Study participating centre
3300AK
Netherlands
Sponsor information
Hospital/treatment centre
Albert Schweitzerplaats 25
Dordecht
3311 AT
Netherlands
| Website | http://www.asz.nl/ |
|---|---|
"ROR" |
https://ror.org/00e8ykd54 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
29/05/2020: No publications found.
16/10/2017: Plain English summary added.
