Cerebral Aneurysm UnrupturedPhase 4PICASANCT04616092
Effect of Preoperative Intravenous Ferric Carboxymaltose for Clipping Surgery
A Phase 4 study testing FEFINJECT in people with Cerebral Aneurysm Unruptured and Iron Deficiency Anemia, run by Seoul National University Hospital.
Trial summary
Hypothesis: Correction of preoperative anemia can reduce the need for intra-/postoperative RBC transfusions and can improve surgical outcomes. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Cerebral Aneurysm Unruptured, Iron Deficiency Anemia, Surgery
- What is being tested?
- FEFINJECT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Nov 2020to Apr 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official 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.
Read the detailed description
Anemia is one of the major risk factors that has been shown to compromise surgical outcome in many fields of surgery. Although red blood cell (RBC) transfusions can be used to correct anemia quickly, RBC transfusions are known to be a risk factor that worsens the outcome of surgery. In cerebrovascular disease, anemia can decrease the delivery of oxygen to brain tissue and can cause cerebral ischemia, which can lead to secondary brain damage. On the other hand, RBC transfusion may increase the viscosity of the blood, thereby reducing the cerebral blood flow, or causing side effects such as vasospasm or thromboembolic event. Therefore, there is a growing need for measures to correct anemia and reduce the number of transfusions in the treatment of cerebrovascular diseases.
The effectiveness of ferric carboxymaltose for postoperative anemia correction in orthopedic and general surgery has been reported in several studies. However, researches on the effect of ferric carboxymaltose to correct preoperative anemia is rare, and there has been no study on the efficacy of ferric carboxymaltose, especially in brain surgery. However, as the population of the elderly grows and the technology of inspection develops, the number of diagnosis of cerebrovascular diseases increases. In particular, the incidence of unruptured intracranial aneurysms (UIA) has increased by 29.7% every year since 2008. Accordingly, clipping sugery, known as the treatment of UIA, has increased by 16.0% every year since 2008.21 Therefore, it is necessary to study the efficacy of ferric carboxymaltose to correct the anemia and to decrease the number of transfusion in clipping surgery for UIA.
Seicean et al. analyzed the effects of preoperative anemia and RBC transfusion on the surgical outcomes of 668 patients who underwent surgery for intracranial aneurysms for 7 years. 29.6 % of 668 patients were diagnosed with anemia, preoperatively. 28.3 % of patients with anemia, and 8.1 % of patients without anemia received RBC transfusions, intra-/postoperatively. Patients with preoperative anemia showed significantly higher frequency of RBC transfusions (p<0.01) in general cohort, and hospital length of stay (LOS) (p<0.01) and the rate of major complications (p=0.02) was significantly higher in the group receiving RBC transfusions. This study have reported that preoperative anemia was predictive of perioperative transfusion in the general and matched cohorts (data not shown). Other studies also demostrated that lower preoperative hemoglobin was assodiated with perioperative transfusion.
Investigators performed 427 patients who underwent clipping surgery for UIAs in 2017 in single institute (Seoul National University Bundang Hospital), where has the biggest cerebrovascular center in Korea and is one of the world's best hospitals for cerebrovascular surgery. Among 427 patients, Investigators retrospectively analysed the relationship between preoperative anemia and postoperative transfusion for 338 patients treated for UIA sized under 15mm and located in anterior circulation to maintain patient consistency. 15.4% of patients who underwent clipping surgery were diagnosed with anemia before surgery. Though Investigators did not check the level of ferritin or transferrin saturation, most patients were suspected of IDA because all patients had no chronic inflammatory disease or underlying disease causing anemia. The mean amount of intraoperative bleeding was 484.5ml, and 45.7% of the patients were given intra-/postoperative transfusion. In conclusion, the frequency of intra-/postoperative RBC transfusion was significantly higher in patients diagnosed with preoperative anemia. (p<0.01) Based on these results, investigators hypothesized that correcting anemia before surgery could reduce the need for postoperative RBC transfusion and conducted a pilot study. From November 2018 to April 2019, FERINJECT 500mg was administered to 12 patients who underwent clipping surgery for UIAs. The average haemoglobin (Hb) increased from 11.4g/dl before FERINJECT to 13.1g/dl on the day of surgery. Three patients (25.0%) received a transfusion after surgery. When investigators retrospectively compared the group with patients without correcting the anemia, investigators concluded that the anemia corrected group significantly lowered the probability of postoperative transfusion. (p <0.01) Accordingly, investigators designed a prospective study to evaluate the effect of preoperative anemia correction using FERINJECT on the need for RBC transfusion and surgical outcome in patients undergoing clipping surgery for UIAs.
- Being tested
- FEFINJECT
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FEFINJECTDrug
FEFINJECT injection
| Study group | Role | What they receive |
|---|---|---|
| FERINJECT Group | Experimental | Patients with FERINJECT injection Receives: Drug: FEFINJECT |
| Observation Group | No intervention | Patients without FERINJECT injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days after operation
Secondary outcomes (2)
Anemia correction (Hemoglobin in g/dl)
Effect of preoperative intravenous ferric carboxymaltose administration on anemia correction in patients with anemia before clipping surgery
Measured: 1 day before sugery
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
Measured: Within 30days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study startNov 2020 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Cerebral Aneurysm UnrupturedStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vifor Pharma
- Responsible party
- Sponsor
- Investigators
- Si Un Lee, Professor, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616092
- Sponsor's protocol ID
- SeoulNUBH_NS
- Acronym
- PICASA
- Status last verified
- Oct 2020
- First submitted
- 26 Oct 2020
- Last updated
- 4 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If requested by the publisher, a serial number can be assigned and shared.
Publications
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.
PubMed 19628806Hendrickson JE, Hillyer CD. Noninfectious serious hazards of transfusion. Anesth Analg. 2009 Mar;108(3):759-69. doi: 10.1213/ane.0b013e3181930a6e.
PubMed 19224780Rosenberg 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.
PubMed 23047622Oddo 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.
PubMed 19265059Naidech 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.
PubMed 20717750Naidech 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.
PubMed 17717494Beattie 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.
PubMed 19212255Dunne 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.
PubMed 11796024Kulier 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.
PubMed 17620512Musallam 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.
PubMed 21982521Lee 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. 2026 Apr;45(2):101646. doi: 10.1016/j.accpm.2025.101646. Epub 2025 Oct 24.
PubMed 41342691
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Intravenous Ferric Carboxymaltose on Postoperative Transfusion Reduction in Anemia Patients Scheduled for Clipping Surgery for Unruptured Intracranial Aneurysms
- ClinicalTrials.gov ID
- NCT04616092
- Acronym / sponsor ID
- PICASA / SeoulNUBH_NS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Vifor Pharma
- Study start
- Nov 2020 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis: Correction of preoperative anemia can reduce the need for intra-/postoperative RBC transfusions and can improve surgical outcomes.
Detailed description
Anemia is one of the major risk factors that has been shown to compromise surgical outcome in many fields of surgery. Although red blood cell (RBC) transfusions can be used to correct anemia quickly, RBC transfusions are known to be a risk factor that worsens the outcome of surgery. In cerebrovascular disease, anemia can decrease the delivery of oxygen to brain tissue and can cause cerebral ischemia, which can lead to secondary brain damage. On the other hand, RBC transfusion may increase the viscosity of the blood, thereby reducing the cerebral blood flow, or causing side effects such as vasospasm or thromboembolic event. Therefore, there is a growing need for measures to correct anemia and reduce the number of transfusions in the treatment of cerebrovascular diseases.
The effectiveness of ferric carboxymaltose for postoperative anemia correction in orthopedic and general surgery has been reported in several studies. However, researches on the effect of ferric carboxymaltose to correct preoperative anemia is rare, and there has been no study on the efficacy of ferric carboxymaltose, especially in brain surgery. However, as the population of the elderly grows and the technology of inspection develops, the number of diagnosis of cerebrovascular diseases increases. In particular, the incidence of unruptured intracranial aneurysms (UIA) has increased by 29.7% every year since 2008. Accordingly, clipping sugery, known as the treatment of UIA, has increased by 16.0% every year since 2008.21 Therefore, it is necessary to study the efficacy of ferric carboxymaltose to correct the anemia and to decrease the number of transfusion in clipping surgery for UIA.
Seicean et al. analyzed the effects of preoperative anemia and RBC transfusion on the surgical outcomes of 668 patients who underwent surgery for intracranial aneurysms for 7 years. 29.6 % of 668 patients were diagnosed with anemia, preoperatively. 28.3 % of patients with anemia, and 8.1 % of patients without anemia received RBC transfusions, intra-/postoperatively. Patients with preoperative anemia showed significantly higher frequency of RBC transfusions (p<0.01) in general cohort, and hospital length of stay (LOS) (p<0.01) and the rate of major complications (p=0.02) was significantly higher in the group receiving RBC transfusions. This study have reported that preoperative anemia was predictive of perioperative transfusion in the general and matched cohorts (data not shown). Other studies also demostrated that lower preoperative hemoglobin was assodiated with perioperative transfusion.
Investigators performed 427 patients who underwent clipping surgery for UIAs in 2017 in single institute (Seoul National University Bundang Hospital), where has the biggest cerebrovascular center in Korea and is one of the world's best hospitals for cerebrovascular surgery. Among 427 patients, Investigators retrospectively analysed the relationship between preoperative anemia and postoperative transfusion for 338 patients treated for UIA sized under 15mm and located in anterior circulation to maintain patient consistency. 15.4% of patients who underwent clipping surgery were diagnosed with anemia before surgery. Though Investigators did not check the level of ferritin or transferrin saturation, most patients were suspected of IDA because all patients had no chronic inflammatory disease or underlying disease causing anemia. The mean amount of intraoperative bleeding was 484.5ml, and 45.7% of the patients were given intra-/postoperative transfusion. In conclusion, the frequency of intra-/postoperative RBC transfusion was significantly higher in patients diagnosed with preoperative anemia. (p<0.01) Based on these results, investigators hypothesized that correcting anemia before surgery could reduce the need for postoperative RBC transfusion and conducted a pilot study. From November 2018 to April 2019, FERINJECT 500mg was administered to 12 patients who underwent clipping surgery for UIAs. The average haemoglobin (Hb) increased from 11.4g/dl before FERINJECT to 13.1g/dl on the day of surgery. Three patients (25.0%) received a transfusion after surgery. When investigators retrospectively compared the group with patients without correcting the anemia, investigators concluded that the anemia corrected group significantly lowered the probability of postoperative transfusion. (p <0.01) Accordingly, investigators designed a prospective study to evaluate the effect of preoperative anemia correction using FERINJECT on the need for RBC transfusion and surgical outcome in patients undergoing clipping surgery for UIAs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FERINJECT Group | Experimental | Drug: FEFINJECTPatients with FERINJECT injection |
| Observation Group | No intervention | –Patients without FERINJECT injection |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FEFINJECTFEFINJECT injection | Drug | FERINJECT Group |
Primary outcome
Red Blood Cell transfusion rate in packs
Time frame: 7 days after operation
Reduction of transfusion rate per patient in hospital resulting from administration of intravenous ferric carboxymaltose for the patients who undergoing clipping surgery
2 secondary outcomes
Anemia correction (Hemoglobin in g/dl)
Time frame: 1 day before sugery
Adverse event rate and hospital length of stay (LOS) in days
Time frame: Within 30days after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Background: PubMed 19628806Dhar 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.
- Background: PubMed 19224780Hendrickson JE, Hillyer CD. Noninfectious serious hazards of transfusion. Anesth Analg. 2009 Mar;108(3):759-69. doi: 10.1213/ane.0b013e3181930a6e.
- Background: PubMed 23047622Rosenberg 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.
- Background: PubMed 19265059Oddo 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.
- Background: PubMed 20717750Naidech 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.
- Background: PubMed 17717494Naidech 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.
- Results publication: PubMed 19212255Beattie 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.
- Results publication: PubMed 11796024Dunne 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.
- Results publication: PubMed 17620512Kulier 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.
- Results publication: PubMed 21982521Musallam 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.
- Derived from this study: PubMed 41342691Lee 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. 2026 Apr;45(2):101646. doi: 10.1016/j.accpm.2025.101646. Epub 2025 Oct 24.
- Individual participant dataSharing planned: No. If requested by the publisher, a serial number can be assigned and shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Si Un Lee, Professor principal investigator
Seoul National University Bundang Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FEFINJECT in people with Cerebral Aneurysm Unruptured and Iron Deficiency Anemia, run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Si Un Lee, Professor (82-10-9207-2124, nsmidget@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Red Blood Cell transfusion rate in packs (time frame: 7 days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04616092, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.