Trial Title:
Blood Transfusion in Patients With Lung Cancer
NCT ID:
NCT05590429
Condition:
Transfusion-Transmitted Infection
Conditions: Official terms:
Transfusion Reaction
Conditions: Keywords:
Hemoglobin, lung canser, complication
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Other
Intervention name:
Blood transfusion
Description:
No intervention
Summary:
The main purpose of approaching the anemic patient is to provide and maintain hemoglobin
levels that will allow oxygen to reach the tissue at an adequate level. This critical
level may vary from patient to patient, the age of the patient and other accompanying
diseases are among the determining factors. The most important factor in transfusion
indication is the insufficiency of cardiopulmonary compensation mechanisms due to anemia
in the patient and the patient becoming symptomatic. Red blood cell (RBC) transfusions
are common in the treatment of cancer patients.
In cancer patients, similar to other patient populations, the indication for RBC
transfusion is to alleviate anemia, which is actually symptomatic. However, the decision
to transfuse should not be guided solely by the hemoglobin concentration.
With this study, it is aimed to develop clinical practices to prevent unnecessary
transfusion practices in lung cancer patients, to encourage the application of other
supportive treatment options, and to take preventive measures before anemia develops
Detailed description:
Blood is a living tissue composed of specific structures, each with distinct functions.
Blood transfusion is a tissue or even organ transplantation. Unnecessary blood
transfusion should not be done, and the missing component should be replaced in the
patient.
The need for transfusion seen in medical diseases is often in the form of chronic anemia,
except for a few conditions that cause sudden bleeding. Repeated transfusions may be
required in these patients during the course of their disease and related problems may
arise. For this reason, while determining the indication for transfusion, it is
absolutely necessary to perform the benefit-harm analysis correctly.
The main purpose of approaching the anemic patient is to provide and maintain hemoglobin
levels that will allow oxygen to reach the tissue at an adequate level. This critical
level may vary from patient to patient, the age of the patient and other accompanying
diseases are among the determining factors. The most important factor in transfusion
indication is the insufficiency of cardiopulmonary compensation mechanisms due to anemia
in the patient and the patient becoming symptomatic. Red blood cell (RBC) transfusions
are common in the treatment of cancer patients.
Generally, patients with oncological and hematological malignancies use approximately 34%
of the RBC source. In cancer patients, similar to other patient populations, the
indication for RBC transfusion is to alleviate anemia, which is actually symptomatic.
However, the decision to transfuse should not be guided solely by the hemoglobin
concentration. No single criterion can be used as an indicator of RBC transfusion.
The clinical condition of the patient must be taken into account. Anemia can be seen in
approximately 90% of patients during chemotherapy treatment. Cytotoxic drugs often cause
the loss, destruction and reduction of RBCs that cause anemia. Especially lung and
gynecological cancers are highly associated with anemia. Platinum-based chemotherapeutics
are often preferred in the treatment of such cancers. Anemia in cancer can reduce quality
of life and increase cancer-related fatigue and may be a poor indicator of clinical
outcomes. That is why, in clinical practice, transfusions are often performed in cancer
patients.
In general, a hemoglobin level of 7 g / dL is a suitable indicator for red blood cell
(RBC) transfusion in stable patients without complications. However, patients with
cardiovascular disease or acute coronary syndrome can be transfused at a hemoglobin level
of 8 g / dL.
Although the indications for transfusion in patients with other types of complications
are unclear, cancer patients have reported improved clinical well-being when kept at
about 7 g / dL in hemoglobin levels, but no study results suggested an absolute
hemoglobin level that is optimal for patients with cancer.
With this study, it is aimed to develop clinical practices to prevent unnecessary
transfusion practices in lung cancer patients, to encourage the application of other
supportive treatment options, and to take preventive measures before anemia develops.
Patients who have been followed up and receiving chemotherapy in our chest diseases
department in the last 5 years will be included in our study. Patients who were diagnosed
with lung cancer between 01/01 / 2014-31 / 12/2018, followed up in the chest diseases
service and given chemotherapy will be included in the study. Patient data will be
retrospectively collected using file records and hospital automation system (clinical
course, blood bank data, consultation records, etc.). The study will begin after the
approval of the ethics committee and will continue for 6 months.
Exclusion Criteria; Patients with known hematological malignancies other than lung
cancer, patients who were diagnosed with anemia before chemotherapy treatment, who
received treatment for this reason, patients who were diagnosed with lung cancer in our
clinic but did not continue chemotherapy treatment in our clinic afterwards, and patients
who are thought to impair data integrity due to incomplete data will be excluded from the
study.
Patients' data to be followed; Exclusion Criteria; Patients with known hematological
malignancies other than lung cancer, patients who were diagnosed with anemia before
chemotherapy treatment, who received treatment for this reason, patients who were
diagnosed with lung cancer in our clinic but did not continue chemotherapy treatment in
our clinic afterwards, and patients who are thought to impair data integrity due to
incomplete data will be excluded from the study.
Patients' data to be followed; Demographic characteristics, comorbid diseases, cancer
type and stage, how long it was followed up with this diagnosis, Hb value before starting
chemotherapy, whether RBC transfusion was performed during the follow-up period, which Hb
value of blood transfusion was applied, how many units of RBC or other blood were taken
during the follow-up period. product replacement, how many cures of chemotherapy they
received in total, which chemotherapy drugs they took, whether there was a delay in
treatment due to treatment-related anemia, the most frequent indications and
complications of transfusion (allergic reaction, febrilereax., infection and
thromboembolic complications), whether they received additional radiotherapy. , whether
they received GMC-SF due to anemia, blood groups, survival times, how many times there
was cancer progression under treatment, and if there is distant metastasis, the location
of metastasis was aimed to be screened.
In the analysis of the data; The compliance of the data to normal distribution will be
examined by Shapiro Wilk and Kolmogorog Smirnov tests. Kruskall-Wallis, Mann-Whitney U,
student-t and chi-square tests will be used for comparisons between groups. General
linner modeling, Wilcowon and Friedman tests will be used in serially tracked data. Data
will be given as percentage, mean (std deviation) and median (minimum-maximum). The
chi-square test will be used to compare qualitative data. Categorical data will be
presented in the form of frequency and percentage.
Criteria for eligibility:
Study pop:
All patients diagnosed with lung cancer and treated
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
Patients over 18 years of age diagnosed with non-small cell lung cancer Patients over 18
years of age diagnosed with small cell lung cancer Patients diagnosed with lung cancer
and undergoing chemotherapy
Exclusion Criteria:
Patients with known hematological malignancies other than lung cancer, patients who were
diagnosed with anemia before chemotherapy treatment, who received treatment for this
reason, patients who were diagnosed with lung cancer in our clinic but did not continue
chemotherapy treatment in our clinic afterwards, patients who are thought to impair data
integrity due to missing data will be excluded from the study
-
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Chest Diseases, Division Of Intensive Care Medicine, Faculty of Medicine, Karadeniz Technical University
Address:
City:
Trabzon
Zip:
61100
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
olcay ayçiçek
Phone:
05324409349
Email:
olaycicek75@gmail.com
Start date:
October 1, 2020
Completion date:
November 30, 2022
Lead sponsor:
Agency:
Karadeniz Technical University
Agency class:
Other
Source:
Karadeniz Technical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05590429
