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Transfusion-Transmitted InfectionNCT05590429

Blood Transfusion in Patients With Lung Cancer

An observational study of Transfusion-Transmitted Infection, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Transfusion-Transmitted Infection
What is being tested?
Blood transfusion
How many people
400 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Oct 2020to 30 Nov 2022
Phase
Observational
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients diagnosed with lung cancer and treated

Who may be able to join

  • 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

Who cannot join

  • 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
  • -

Trial locations and contacts

1 site in 1 country.

OLCAY AYCICEK, MD contact

05324409349

olcayaycicek@yahoo.com

Turkey (Türkiye)1 site, 1 recruiting
  • Department of Chest Diseases, Division Of Intensive Care Medicine, Faculty of Medicine, Karadeniz Technical University

    Trabzon, 61100

    olcay ayçiçek, 05324409349, olaycicek75@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Frequency and Complications of Blood Transfusion in Patients With Lung Cancer

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

Read the 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.

Being tested
Blood transfusion
Keywords
Hemoglobin, lung canser, complication
Medical subject headings
Transfusion Reaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood transfusionOther

    No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. evaluate the relationship between blood transfusion frequency and disease prognosis

    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.

    Measured: 01.10.2020-01.06.2022

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2022
  2. Study start1 Oct 2020
  3. Primary completion2 Nov 2022 (estimated)
  4. Study completion30 Nov 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05590429
Sponsor's protocol ID
24237859-782
Status last verified
Apr 2022
First submitted
13 Jun 2021
Last updated
21 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Transfusion-Transmitted Infection, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).

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 1 inclusion and 2 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 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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.

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 OLCAY AYCICEK, MD (05324409349, olcayaycicek@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

evaluate the relationship between blood transfusion frequency and disease prognosis (time frame: 01.10.2020-01.06.2022). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 21 Oct 2022.

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