|- candidate number||14043|
|- NTR Number||NTR3731|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-nov-2012|
|- Secondary IDs||NL35394.101.11 CCMO|
|- Public Title||“Pre-operatieve Iron” use as blood sparing technique in Orthopedic Surgery (THP en TKP surgery, elective and no revision surgery).|
|- Scientific Title||“Pre-operatieve Iron” use as blood sparing technique in Orthopedic Surgery (THP en TKP surgery, elective and no revision surgery).|
|- ACRONYM||POP-i study|
|- hypothesis||In this research we will investigate if i.v. iron therapy can become a method of blood saving therapy for orthopedic surgery and can replace erytropoietin.|
|- Healt Condition(s) or Problem(s) studied||Orthopedic surgery, Total hip replacement, Total knee arthroplasty, i.v. iron, Epo|
|- Inclusion criteria||Orthopedic patients planned for primary Total Hip and total Knee replacement operations with an preoperative Hb > 6,1 and ≤ 8,1 mmol/l.|
|- Exclusion criteria||1. Revision operations;|
2. Preop Hb <= 6,1 mmol/l or > 8,2 mmol/l;
3. All patients who wish not to receive blood transfusions;
4. Uncontrolled hypertension (Diastolic blood pressure > 95 mm Hg);
5. Patients planned for preoperative autologous donation, cell salvage, wound reinfusion;
6. Severe cardiac compromised patients, uncontrolled hypertension, severe disease periferal arteries, art carotis or art cerebralis;
7. Recent myocardial infarction of CVA or instable angina pectoris or heart failure;
8. Prone for trombosis (f.i. Factor V Leiden);
9. All patients with Hb-globinopathy such as sickle cell anemia or thalassemia;
10. Patients with oncological processes except curred malignancy or skin cancer;
12. Patients with ciclosporin therapy;
13. Unpossible to give prophylactic anticoagulant;
14. Allergy Epo or i.v. iron or additives;
15. Infected wound, infected prothesis, infectious process at the moment of inclusion;
16. Epileptic, chronic kidney and liver insufficiency;
17. Iron diseases.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2013|
|- planned closingdate||1-jan-2015|
|- Target number of participants||1020|
|- Interventions||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).
|- Primary outcome||Can ferric carboxymaltose effectively reduce RBC transfusion rate compared to controles in elective orthopaedic surgery patients?
Primary endpoints: Rate of transfused patients.
|- Secondary outcome||1. Is 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?).
Hospital stay, postoperative complications, time needed for revalidation, measurement of quality of life, total cost treatment, Hb-levels preo- and postoperatively, amount of RBC per patient, safety of IV iron.
|- Timepoints||3 months follow up.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. W.M.M. Koopman-van Gemert|
|- CONTACT for SCIENTIFIC QUERIES||Dr. W.M.M. Koopman-van Gemert|
|- Sponsor/Initiator ||Albert Schweitzer Ziekenhuis |
(Source(s) of Monetary or Material Support)
|Albert Schweitzer Ziekenhuis, Dordrecht |
|- Brief summary||Investigated are patients planned for a primary, elective total hip or total knee replacement operation. Patients with a Hb > 6,1 and ≤ 8,1 mmol/l, measured 2 weeks before visit to the preoperative poli of the anesthesiologist, will be included. It will be a three arm, Randomized Controlled trial. Patients in the IV iron intervention group will receive 1 gr i.v. iron on the day care at the day of the visit. Patients in the Epo group will receive 4 weekly injections of 40.000 I.U. of Epo, supported bij oral iron therapy. In the control group patients will receive standard care. In case of measured iron deficiency, patient willen receive oral iron therapy. Al patients will be operated 4 weeks after start of therapy. |
Both groups will be transfused following the CBO guideline Blood Transfusion 2011, (4,5,6, Flexinorm).
|- Main changes (audit trail)|
|- RECORD||30-nov-2012 - 16-dec-2012|