Effect of Preoperative Intravenous Ferric Carboxymaltose for Clipping Surgery (PICASA)

November 1, 2020 updated by: Seoul National University Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: FERINJECT Group
Patients with FERINJECT injection
Drug: FEFINJECT
FEFINJECT injection
NO_INTERVENTION: Observation Group
Patients without FERINJECT injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 days after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anemia correction (Hemoglobin in g/dl)
Time Frame: 1 day before sugery
Effect of preoperative intravenous ferric carboxymaltose administration on anemia correction in patients with anemia before clipping surgery
1 day before sugery
Adverse event rate and hospital length of stay (LOS) in days
Time Frame: Within 30days after operation
Effect of preoperative intravenous ferric carboxymaltose administration on reduction of adverse event and hospital LOS after clipping surgery
Within 30days after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Vifor Pharma

Investigators

  • Principal Investigator: Si Un Lee, Professor, Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 1, 2020

Primary Completion (ANTICIPATED)

November 1, 2022

Study Completion (ANTICIPATED)

April 1, 2023

Study Registration Dates

First Submitted

October 26, 2020

First Submitted That Met QC Criteria

November 1, 2020

First Posted (ACTUAL)

November 4, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 1, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SeoulNUBH_NS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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