NCT04616092

Brief Summary

Hypothesis: Correction of preoperative anemia can reduce the need for intra-/postoperative RBC transfusions and can improve surgical outcomes.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2020

Typical duration for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

November 4, 2020

Status Verified

October 1, 2020

Enrollment Period

2 years

First QC Date

October 26, 2020

Last Update Submit

November 1, 2020

Conditions

Cerebral Aneurysm UnrupturedIron Deficiency AnemiaSurgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Anemia correction (Hemoglobin in g/dl)

    1 day before sugery

  • Adverse event rate and hospital length of stay (LOS) in days

    Within 30days after operation

Study Arms (2)

FERINJECT Group

EXPERIMENTAL

Patients with FERINJECT injection

Drug: FEFINJECT

Observation Group

NO INTERVENTION

Patients without FERINJECT injection

Interventions

FEFINJECTDRUG

FEFINJECT injection

FERINJECT Group

Eligibility Criteria

Age19 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients: 19≤ age \< 80
  • 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%
  • Patients with UIAs A. UIAs located in anterior circulation B. Size \< 15mm C. Operable with clipping alone

You may not qualify if:

  • Age: \<19, ≥80
  • Hb\<10
  • Anemia except IDA A. Anaplastic anemia B. Hemolytic anemia C. Anemia with chronic disease
  • UIAs located in posterior circulation
  • Size of UIA ≥ 15mm
  • Not operable with clipping alone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • 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.

    PMID: 19628806BACKGROUND

  • Hendrickson JE, Hillyer CD. Noninfectious serious hazards of transfusion. Anesth Analg. 2009 Mar;108(3):759-69. doi: 10.1213/ane.0b013e3181930a6e.

    PMID: 19224780BACKGROUND

  • 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.

    PMID: 23047622BACKGROUND

  • 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.

    PMID: 19265059BACKGROUND

  • 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.

    PMID: 20717750BACKGROUND

  • 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. doi: 10.1097/01.CCM.0000284516.17580.2C.

    PMID: 17717494BACKGROUND

  • 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.

    PMID: 19212255RESULT

  • 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. doi: 10.1006/jsre.2001.6330.

    PMID: 11796024RESULT

  • 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 on outcome in patients undergoing coronary artery bypass graft surgery. Circulation. 2007 Jul 31;116(5):471-9. doi: 10.1161/CIRCULATIONAHA.106.653501. Epub 2007 Jul 9.

    PMID: 17620512RESULT

  • 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 study. Lancet. 2011 Oct 15;378(9800):1396-407. doi: 10.1016/S0140-6736(11)61381-0. Epub 2011 Oct 5.

    PMID: 21982521RESULT

  • Lee SU, Sung SB, Koo CH, Lim S, Lee SH, Choi TW, Kim YD, Ban SP, Kwon OK, Bang JS. Effect of Preoperative Intravenous Ferric Carboxymaltose on Postoperative Transfusion Reduction in Iron Deficiency Anemia Patients Scheduled for Clipping Surgery for Unruptured Intracranial Aneurysms: The PICASA Trial - A Single Center, Single-Blind Randomized Clinical Trial. Anaesth Crit Care Pain Med. 2025 Oct 24;45(2):101646. doi: 10.1016/j.accpm.2025.101646. Online ahead of print.

    PMID: 41342691DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Si Un Lee, Professor

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Si Un Lee, Professor

CONTACT

82-10-9207-2124nsmidget@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2020

First Posted

November 4, 2020

Study Start

November 1, 2020

Primary Completion

November 1, 2022

Study Completion

April 1, 2023

Last Updated

November 4, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

If requested by the publisher, a serial number can be assigned and shared.