The Benefits of a Preoperative Anemia Management Program
Palabras clave
Abstracto
Descripción
Patient blood management (PBM) involves the timely and conscientious use of the current best evidence in making medical and surgical decisions about the care of patients to maintain red blood cell levels, optimize blood clotting, and minimize blood loss, in an effort to improve patient outcome. PBM focuses on the treatment of the individual patient and comprises transfusion therapy and drug therapy. PBM is based on three points: (1) optimization of the (preoperative) red blood cell volume, (2) reduction of diagnostic, therapeutic, or intraoperative blood loss, and (3) increasing individual tolerance towards anemia and accurate blood transfusion triggers. PBM primarily identifies patients at risk for transfusion and provides a management plan aimed at reducing or eliminating anemia and the need for blood transfusion donated from someone other than the patient (allogeneic transfusion), thus reducing the risks, blood bank inventory pressures, and the escalating costs associated with transfusion. The implementation of a formal UAB Preoperative Anemia Management Program (PAMP) may help achieve consistent PBM.
Efforts will be made to coordinate patients' scheduled surgery date and their initial evaluation in the UAB Highlands Hospital Preoperative Assessment, Consultation, and Treatment (HPACT) Clinic, so that their first PACT Clinic visit occurs approximately 14 days prior to the planned total hip replacement or total knee replacement
fechas
| Verificado por última vez: | 04/30/2015 |
| Primero enviado: | 03/19/2013 |
| Inscripción estimada enviada: | 06/23/2013 |
| Publicado por primera vez: | 06/26/2013 |
| Última actualización enviada: | 05/25/2015 |
| Última actualización publicada: | 05/27/2015 |
| Fecha de los primeros resultados enviados: | 03/19/2015 |
| Fecha de los primeros resultados de CC enviados: | 05/25/2015 |
| Fecha de los primeros resultados publicados: | 05/27/2015 |
| Fecha de inicio real del estudio: | 03/31/2013 |
| Fecha estimada de finalización primaria: | 12/31/2014 |
| Fecha estimada de finalización del estudio: | 12/31/2014 |
Condición o enfermedad
Intervención / tratamiento
Drug: Anemia Treatment Group (AMG)
Drug: Anemia Treatment Group (AMG)
Other: Blood Transfusion
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Active Comparator: Anemia Treatment Group (AMG) Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively. | Drug: Anemia Treatment Group (AMG) AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at -14 days and -7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2. |
| Other: Conventional Treatment Group (CTG) Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening. | |
| Other: Non Anemia Group (NAG) Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care. |
Criterio de elegibilidad
| Edades elegibles para estudiar | 19 Years A 19 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: 1. 19 years to 80 years of age 2. American Society of Anesthesiologists 1-3 status 3. Undergoing total hip arthroplasty for osteoarthritis, (either a primary or replacement procedure, but not a revision procedure) OR avascular necrosis (AVN); OR undergoing total knee arthroplasty (replacement) for osteoarthritis Exclusion Criteria: 1. American Society of Anesthesiologists 4 status 2. Severe anemia, defined as a hematocrit of < 30% 3. History of hypercoagulability or thrombophilia (e.g, factor V Leiden) 4. History of deep venous thrombosis (DVT) or venous thromboembolism (VTE) within last 12 months 5. Current use of anticoagulants (e.g., heparin, warfarin, dabigatran, etc) 6. Diagnosis of chronic renal insufficiency requiring dialysis 7. Morbid obesity (BMI > 40) 8. History of allergic reaction to intravenous iron 9. History of allergic reaction to an erythropoietic stimulating agent (ESA) 10. History of sickle cell disease 11. History of hemochromatosis 12. History of liver dysfunction or congestive heart failure 13. History of substance abuse disorder 14. History of major psychiatric disorder (e.g., major depression, bipolar disorder, axis II personality disorder, schizophrenia) 15. Uncontrolled hypertension (defined as a systolic pressure ≥ 160 mmHg and/or a diastolic pressure ≥ 110 mmHg) 16. History of uncontrolled cardiac arrhythmias, cerebrovascular accident (CVA), transient ischemic attack (TIA), acute coronary syndrome (ACS), or other arterial thrombosis. ACS includes unstable angina, Q wave myocardial infarction (QwMI), and non-Q wave myocardial infarction (NQMI) within 6 months 17. History of pure red cell aplasia (PRCA) after treatment with an ESA 18. History of seizure disorder 19. Any active/current cancer within the last 12 months (not including non-melanoma skin cancer) 20. Pregnancy or lactation 21. Non-native English speaker (because validated Spanish language versions of two of the patient questionnaires are not available) |
Salir
Medidas de resultado primarias
1. Number of Subjects Requiring at Least One Blood Transfusion During Surgery. [During surgery (less than 1 day)]
2. Number of Subjects With Blood Transfusions After Surgery and Prior to Discharge From Hospital [post surgery through discharge, an average of 2 days]
3. Number of Subjects Requiring Blood Transfusions Post Hospital Discharge Through 90 Days After Surgery [post hospital discharge through 90 days after surgery]
Medidas de resultado secundarias
1. Health-related Quality of Life [Baseline at 14 days before, on hospital discharge, and at two-weeks, 30 days, 60 days and 90 days after surgery]
