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The Benefits of a Preoperative Anemia Management Program (PAMP)

26 mei 2015 bijgewerkt door: Thomas R. Vetter, MD, MPH, University of Alabama at Birmingham
The goal of this study is to gain further insight into the comparative effectiveness of treating patients, who are found to be anemic before their elective surgery, with a series of weekly subcutaneous doses of a drug given before surgery, which stimulates the natural production of red blood cells (a so-called erythropoietic stimulating agent [ESA]) along with intravenous iron, in reducing the need for blood transfusions (donated by someone other than the patient) during and after adult total hip arthroplasty (hip replacement surgery). The effects of a Preoperative Anemia Management Program (PAMP) on the patient's quality of recovery, health-related quality of life, fatigue, and rehabilitation pattern after surgery will also be examined. A cost-effectiveness analysis will be performed to compare the cost of these commercially available, FDA-approved medications versus the cost of transfused blood

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Studietype

Ingrijpend

Inschrijving (Werkelijk)

51

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Alabama
      • Birmingham, Alabama, Verenigde Staten, 35294
        • UAB Highlands Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

19 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Geneesmiddel: Iron sucrose
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.
Andere namen:
  • (Venofer®)
Geneesmiddel: Epoetin Alfa
AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an 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).
Andere namen:
  • PROCRIT®
Ander: Blood Transfusion
An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability.
Ander: 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.
Ander: Blood Transfusion
An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability.
Ander: Non Anemia Group (NAG)
Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.
Ander: Blood Transfusion
An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Subjects Requiring at Least One Blood Transfusion During Surgery.
Tijdsspanne: During surgery (less than 1 day)
The number of subjects who had blood transfusions (at least 1) during surgery
During surgery (less than 1 day)
Number of Subjects With Blood Transfusions After Surgery and Prior to Discharge From Hospital
Tijdsspanne: post surgery through discharge, an average of 2 days
Number of subjects that had at least 1 blood transfusion from the end of surgery until discharge from hospital
post surgery through discharge, an average of 2 days
Number of Subjects Requiring Blood Transfusions Post Hospital Discharge Through 90 Days After Surgery
Tijdsspanne: post hospital discharge through 90 days after surgery
number of subjects requiring blood transfusions after hospital discharge through 90 days after surgery
post hospital discharge through 90 days after surgery

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Health-related Quality of Life
Tijdsspanne: Baseline at 14 days before, on hospital discharge, and at two-weeks, 30 days, 60 days and 90 days after surgery
Health-related quality of life measured with the SF-12V2; Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Questionnaire; Oxford Hip Score or Oxford Knee Score; and Multidimensional Assessment of Fatigue (MAF) Scale
Baseline at 14 days before, on hospital discharge, and at two-weeks, 30 days, 60 days and 90 days after surgery

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Alabama at Birmingham

Onderzoekers

  • Hoofdonderzoeker: Thomas R Vetter, MD, MPH, University of Alabama at Birmingham

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2013

Primaire voltooiing (Werkelijk)

1 januari 2015

Studie voltooiing (Werkelijk)

1 januari 2015

Studieregistratiedata

Eerst ingediend

20 maart 2013

Eerst ingediend dat voldeed aan de QC-criteria

24 juni 2013

Eerst geplaatst (Schatting)

27 juni 2013

Updates van studierecords

Laatste update geplaatst (Schatting)

28 mei 2015

Laatste update ingediend die voldeed aan QC-criteria

26 mei 2015

Laatst geverifieerd

1 mei 2015

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • F130117001

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