Trial Title:
Management of Preoperative Anaemia in Surgical Oncology
NCT ID:
NCT05505006
Condition:
Anemia
Tumor
Conditions: Official terms:
Anemia
Folic Acid
Vitamin B 12
Conditions: Keywords:
anemia
surgical oncology
transfusion
patient blood management
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
- Institution of an Anemia Clinic to identify all cancer patients with anemia before
surgery
- Treatment of treatable causes of anemia in all cancer patients within three weeks
before surgery; in particular, iron deficiency (ID), folate deficiency and B12
deficiency
- Collection of data concerning transfusions in the peri-operative period
- Collection of peri-operative outcomes such as in-hospital mortality, myocardial
infarction, ischemic stroke, acute renal failure, pneumonia, or sepsis, and Hb
levels at discharge
- Comparison of data relating to transfusions and outcomes with those obtained in a
historical cohort of anemic patients eligible for oncological surgery for malignant
tumors, matched by age, sex, and pathology enrolled in the three years 2017-2019
- Evaluation of hepcidin levels in anemic cancer patients (explorative aim)
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Ferric Carboxymaltose Injection
Description:
Anemic patients with ID will receive i.v. iron. Dosage will be based on Hb level and
patient body weight.
Arm group label:
Cancer patients with anemia (i.e. Hb <12 g/dl if females, <13 g/dL if males)
Other name:
i.v. iron
Intervention type:
Drug
Intervention name:
Folic acid
Description:
Anemic patients with folate deficiency will receive folic acid 5 mg per day for 1 month
Arm group label:
Cancer patients with anemia (i.e. Hb <12 g/dl if females, <13 g/dL if males)
Other name:
Folate
Intervention type:
Drug
Intervention name:
B12
Description:
Anemic patients with B12 deficiency will receive B vitamin complex 1 tablet per day for 1
month
Arm group label:
Cancer patients with anemia (i.e. Hb <12 g/dl if females, <13 g/dL if males)
Other name:
cobalamin
Summary:
Preoperative anemia is detrimental in surgical patients, and its treatment with
transfusions can further worsen outcomes, including increased hospital stay and
mortality. Transfusions are also highly costly. In 2010, the World Health Organization
endorsed the adoption of Patient Blood Management (PBM) programs, i.e., patient-centered
multidisciplinary activities, including recognition and treatment of preoperative anemia.
While the latter has been proved effective in reducing transfusions in setting like
elective orthopedic surgery, widespread adoption is still lacking. Moreover, little is
known about surgical oncology, a particular setting posing unique challenging. This
change-promoting project attempts to fill this knowledge gap by establishing a
multidisciplinary team aimed at optimal management of preoperative anemia in
hepatobiliary/pancreas/gastrointestinal/renal surgical oncology. The primary endpoint is
the reduction of transfusions, along with safer patient outcomes as compared to the
historical series.
Detailed description:
BACKGROUND: Preoperative anemia is frequent in patients undergoing major surgery, varying
from nearly 35% in elective orthopedic surgery (EOS) to >75% in colon cancer. Mounting
data have shown that anemia is independently associated with an increased risk of
morbidity and mortality in surgical patients. This is true even for mild-degree anemia,
which is frequently overlooked. Of note, treatment of anemia with transfusions does not
ameliorate the risk but instead appears to raise further perioperative morbidity,
hospital length of stay, and mortality. Transfusions have adverse immunomodulatory
effects that can increase infectious complications or cancer recurrence. Indeed, it is
increasingly recognized that transfusions are one of the most costly and overused
treatments in modern medicine. This has led to the implementation of Patient Blood
Management (PBM) programs, i.e., patient-centered, multidisciplinary activities to
promote safe and evidence-based use of transfusions. Recognition and treatment of
preoperative anemia is a significant pillar of PBM, with proven efficacy in certain types
of surgery, i.e., EOS. This has been facilitated by recent advances in the knowledge of
the pathophysiology of iron, whose deficiency represents a common and treatable form of
anemia in surgical patients. Nevertheless, evidence is scanty in surgical patients with
malignancies, a particular subgroup that poses unique challenges.
Hypothesis and Significance: Recognition and treatment of preoperative anemia in surgical
oncology through a well-organized, multidisciplinary Anemia Clinic should decrease blood
transfusions, ultimately leading to better clinical outcomes and cost savings.
METHODOLOGIES and STATISTICAL ANALYSES: Evaluation and treatment of preoperative anemia
will be performed as follows: we will perform a minimum panel of exams, i.e., complete
blood count (CBC), creatinine, C-reactive protein, ferritin, transferrin saturation
(TSAT), and circulating folate/B12 levels, to assess the presence of anemia, and to
identify potentially correctable causes. On the same day on which the patient performs
lab analyses in the morning, the surgeon will alert the Anemia Clinic with the patient's
ID digital code. Case-manager MD at Anemia Clinic will evaluate lab results as soon they
become available (expected time 3-4 hours after blood drawing) through the e-health
system. Anemic patients will be invited to attend the Anemia Clinic the day after. They
will be clinically evaluated, and treatment for anemia will be immediately
prescribed/performed.
Core statistical analyses regarding transfusion use and patients' outcomes will be
entrusted to external independent statisticians through subcontract. The diagnostic
performance of hepcidin will be investigated through Area Under the Curve Receiving
Operating Characteristic (AUC-ROC) and its prognostic implications by Kaplan-Meier
curves.
The duration of the presented project is calculated as 36 months and will be divided into
3 different milestones as follows:
- M1: Study organization and coordination among the Units (study protocol preparation,
procedures implementation for managing patient flow across units).
- M2: 24 months of Patient Enrolment (evaluation of preoperative hematological
parameters and suitable treatment, surgery, postoperative evaluation) and ad interim
follow-up evaluation after 1 month from the surgery.
- M3: statistical evaluation of results, publication preparation, and evaluation of
the possible implementation of new improved internal guidelines for treating anemia
in cancer patients.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Signature of informed consent
- Eligibility to elective surgery for malignant oncological pathology.
- Presence of pre-operative anemia (Hb <12 g/dL females, <13 g/dL males)
- Age >=18 years
Exclusion Criteria:
- Patients with chronic anemia, regularly transfused
- Patients with Hemochromatosis
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Azienda Ospedaliera Universitaria Integrata di Verona
Address:
City:
Verona
Zip:
37134
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Domenico Girelli, Prof.
Phone:
+ 39 0458124262
Email:
domenico.girelli@aovr.veneto.it
Investigator:
Last name:
Domenico Girelli, Prof.
Email:
Principal Investigator
Investigator:
Last name:
Alfredo Guglielmi, Prof.
Email:
Sub-Investigator
Investigator:
Last name:
Giorgio Gandini, MD
Email:
Sub-Investigator
Investigator:
Last name:
Giovanni Marchegiani, MD
Email:
Sub-Investigator
Start date:
March 2, 2021
Completion date:
August 13, 2024
Lead sponsor:
Agency:
Azienda Ospedaliera Universitaria Integrata Verona
Agency class:
Other
Source:
Azienda Ospedaliera Universitaria Integrata Verona
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05505006
