Surgery Clinical Trial
— PICASAOfficial title:
Effect of Preoperative Intravenous Ferric Carboxymaltose on Postoperative Transfusion Reduction in Anemia Patients Scheduled for Clipping Surgery for Unruptured Intracranial Aneurysms
Hypothesis: Correction of preoperative anemia can reduce the need for intra-/postoperative RBC transfusions and can improve surgical outcomes.
Status | Not yet recruiting |
Enrollment | 130 |
Est. completion date | April 2023 |
Est. primary completion date | November 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 79 Years |
Eligibility | Inclusion Criteria: 1. Adult patients: 19= age < 80 2. Patients with IDA (All of the following conditions must be met) A. Hb: female (10=Hb<12g/dl), male (10=Hb<13g/dl) B. Ferritin < 100ng/ml C. Transferrin saturation<20% 3. Patients with UIAs A. UIAs located in anterior circulation B. Size < 15mm C. Operable with clipping alone Exclusion Criteria: 1. Age: <19, =80 2. Hb<10 3. Anemia except IDA A. Anaplastic anemia B. Hemolytic anemia C. Anemia with chronic disease 4. UIAs located in posterior circulation 5. Size of UIA = 15mm 6. Not operable with clipping alone |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | Vifor Pharma |
Beattie WS, Karkouti K, Wijeysundera DN, Tait G. Risk associated with preoperative anemia in noncardiac surgery: a single-center cohort study. Anesthesiology. 2009 Mar;110(3):574-81. doi: 10.1097/ALN.0b013e31819878d3. — View Citation
Dhar R, Zazulia AR, Videen TO, Zipfel GJ, Derdeyn CP, Diringer MN. Red blood cell transfusion increases cerebral oxygen delivery in anemic patients with subarachnoid hemorrhage. Stroke. 2009 Sep;40(9):3039-44. doi: 10.1161/STROKEAHA.109.556159. Epub 2009 Jul 23. — View Citation
Dunne JR, Malone D, Tracy JK, Gannon C, Napolitano LM. Perioperative anemia: an independent risk factor for infection, mortality, and resource utilization in surgery. J Surg Res. 2002 Feb;102(2):237-44. — View Citation
Hendrickson JE, Hillyer CD. Noninfectious serious hazards of transfusion. Anesth Analg. 2009 Mar;108(3):759-69. doi: 10.1213/ane.0b013e3181930a6e. Review. — View Citation
Kulier A, Levin J, Moser R, Rumpold-Seitlinger G, Tudor IC, Snyder-Ramos SA, Moehnle P, Mangano DT; Investigators of the Multicenter Study of Perioperative Ischemia Research Group; Ischemia Research and Education Foundation. Impact of preoperative anemia — View Citation
Musallam KM, Tamim HM, Richards T, Spahn DR, Rosendaal FR, Habbal A, Khreiss M, Dahdaleh FS, Khavandi K, Sfeir PM, Soweid A, Hoballah JJ, Taher AT, Jamali FR. Preoperative anaemia and postoperative outcomes in non-cardiac surgery: a retrospective cohort s — View Citation
Naidech AM, Jovanovic B, Wartenberg KE, Parra A, Ostapkovich N, Connolly ES, Mayer SA, Commichau C. Higher hemoglobin is associated with improved outcome after subarachnoid hemorrhage. Crit Care Med. 2007 Oct;35(10):2383-9. — View Citation
Naidech AM, Shaibani A, Garg RK, Duran IM, Liebling SM, Bassin SL, Bendok BR, Bernstein RA, Batjer HH, Alberts MJ. Prospective, randomized trial of higher goal hemoglobin after subarachnoid hemorrhage. Neurocrit Care. 2010 Dec;13(3):313-20. doi: 10.1007/s12028-010-9424-4. — View Citation
Oddo M, Milby A, Chen I, Frangos S, MacMurtrie E, Maloney-Wilensky E, Stiefel M, Kofke WA, Levine JM, Le Roux PD. Hemoglobin concentration and cerebral metabolism in patients with aneurysmal subarachnoid hemorrhage. Stroke. 2009 Apr;40(4):1275-81. doi: 10.1161/STROKEAHA.108.527911. Epub 2009 Mar 5. — View Citation
Rosenberg NF, Koht A, Naidech AM. Anemia and transfusion after aneurysmal subarachnoid hemorrhage. J Neurosurg Anesthesiol. 2013 Jan;25(1):66-74. doi: 10.1097/ANA.0b013e31826cfc1d. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Red Blood Cell transfusion rate in packs | Reduction of transfusion rate per patient in hospital resulting from administration of intravenous ferric carboxymaltose for the patients who undergoing clipping surgery | 7 days after operation | |
Secondary | Anemia correction (Hemoglobin in g/dl) | Effect of preoperative intravenous ferric carboxymaltose administration on anemia correction in patients with anemia before clipping surgery | 1 day before sugery | |
Secondary | Adverse event rate and hospital length of stay (LOS) in days | Effect of preoperative intravenous ferric carboxymaltose administration on reduction of adverse event and hospital LOS after clipping surgery | Within 30days after operation |
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