AnemiaNCT05833178
The Effect of Blood Tests Performed Within the Routine Protocol in the Surgical Intensive Care Unit on Hemoglobin Levels
An observational study of Anemia, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
Examination of blood samples is inevitable in intensive care units. Routine blood samples can be an important cause for anemia. In this study, we aimed to examine how our blood collection routine affects hemoglobin values. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- Drawn Blood Volume
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 31 May 2023
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients over the age of 18 who were followed up in the intensive care unit by our clinic and treated for more than 48 hours were included in the study.
Who may be able to join
- Patients followed in the intensive care unit for more than 48 hours, ≥18-year-old
Who cannot join
- Patients not followed up by our clinic,≤18-year-old
Trial locations and contacts
1 site in 1 country.
About this study
Examination of blood samples is inevitable in intensive care units. Routine blood samples can be an important cause for anemia. In this study, we aimed to examine how our blood collection routine affects hemoglobin values.
Read the detailed description
Blood tests for follow-up and treatment are widely used in intensive care units (ICU). Although its etiology is very diverse, phlebotomy performed due to frequent laboratory tests is among the preventable causes of anemia. In this observational study, blood tests performed on patients treated in intensive care units followed up in our clinic between 01.April.2023 - 31.May.2023 (2 months) will be examined. Patients' age, presence of additional disease, indication for admission to the unit, Acute Physiology and Chronic Health Assessment II (APACHE II), Sequential Organ Failure Assessment (SOFA) and Glasgow coma scale (GCS), hemoglobin values will be recorded. The daily blood test will record the amount of blood drawn for analysis (in milliliters), where it was taken from (peripheral, central venous or arterial catheter), and the amount of excess blood. Statistical analysis will be performed in terms of patient characteristics, routine blood volumes and development of anemia.
- Conditions
- Anemia
- Being tested
- Drawn Blood Volume
- Keywords
- Intensive care unit, Routine blood sample, Overdrawn
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drawn Blood VolumeBehavioural
Hemoglobine Changes
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of blood volume drawn for daily routine in intensive care
Daily routine blood test and blood volume determination in intensive care patients
Measured: 2 months
Secondary outcomes (1)
Anemia
Evaluation of how daily routine blood drawn affects patients' hemoglobin values in intensive care patients
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start1 Apr 2023
- Primary completion30 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dilan akyurt, Samsun University
- Investigators
- Mustafa SÜREN, Study director, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833178
- Sponsor's protocol ID
- SUKAEK-2023 5/22
- Status last verified
- Jun 2023
- First submitted
- 15 Apr 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
Publications
Helmer P, Hottenrott S, Steinisch A, Roder D, Schubert J, Steigerwald U, Choorapoikayil S, Meybohm P. Avoidable Blood Loss in Critical Care and Patient Blood Management: Scoping Review of Diagnostic Blood Loss. J Clin Med. 2022 Jan 10;11(2):320. doi: 10.3390/jcm11020320.
PubMed 35054014Siegal DM, Manning N, Jackson Chornenki NL, Hillis CM, Heddle NM. Devices to Reduce the Volume of Blood Taken for Laboratory Testing in ICU Patients: A Systematic Review. J Intensive Care Med. 2020 Oct;35(10):1074-1079. doi: 10.1177/0885066618810374. Epub 2018 Nov 27.
PubMed 30482081
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Blood Tests Performed Within the Routine Protocol in the Surgical Intensive Care Unit on Hemoglobin Levels
- ClinicalTrials.gov ID
- NCT05833178
- Acronym / sponsor ID
- SUKAEK-2023 5/22
- Conditions
- Anemia
- Keywords
- Intensive care unit, Routine blood sample, Overdrawn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 27 Apr 2023 (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.
Examination of blood samples is inevitable in intensive care units. Routine blood samples can be an important cause for anemia. In this study, we aimed to examine how our blood collection routine affects hemoglobin values.
Detailed description
Blood tests for follow-up and treatment are widely used in intensive care units (ICU). Although its etiology is very diverse, phlebotomy performed due to frequent laboratory tests is among the preventable causes of anemia. In this observational study, blood tests performed on patients treated in intensive care units followed up in our clinic between 01.April.2023 - 31.May.2023 (2 months) will be examined. Patients' age, presence of additional disease, indication for admission to the unit, Acute Physiology and Chronic Health Assessment II (APACHE II), Sequential Organ Failure Assessment (SOFA) and Glasgow coma scale (GCS), hemoglobin values will be recorded. The daily blood test will record the amount of blood drawn for analysis (in milliliters), where it was taken from (peripheral, central venous or arterial catheter), and the amount of excess blood. Statistical analysis will be performed in terms of patient characteristics, routine blood volumes and development of anemia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 18 who were followed up in the intensive care unit by our clinic and treated for more than 48 hours were included in the study.
Key inclusion criteria (1 listed)
- Patients followed in the intensive care unit for more than 48 hours, ≥18-year-old
Key exclusion criteria (1 listed)
- Patients not followed up by our clinic,≤18-year-old
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 |
|---|---|---|
| Drawn Blood VolumeHemoglobine Changes | Behavioural | – |
Primary outcome
Evaluation of blood volume drawn for daily routine in intensive care
Time frame: 2 months
Daily routine blood test and blood volume determination in intensive care patients
1 secondary outcome
Anemia
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Background: PubMed 35054014Helmer P, Hottenrott S, Steinisch A, Roder D, Schubert J, Steigerwald U, Choorapoikayil S, Meybohm P. Avoidable Blood Loss in Critical Care and Patient Blood Management: Scoping Review of Diagnostic Blood Loss. J Clin Med. 2022 Jan 10;11(2):320. doi: 10.3390/jcm11020320.
- Background: PubMed 30482081Siegal DM, Manning N, Jackson Chornenki NL, Hillis CM, Heddle NM. Devices to Reduce the Volume of Blood Taken for Laboratory Testing in ICU Patients: A Systematic Review. J Intensive Care Med. 2020 Oct;35(10):1074-1079. doi: 10.1177/0885066618810374. Epub 2018 Nov 27.
- Choosing WiselyLink provided by the sponsor.
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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.
Mustafa SÜREN study director
Samsun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, run by Samsun 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 1 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: finished, as of the sponsor's last update on 15 Jun 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of blood volume drawn for daily routine in intensive care (time frame: 2 months). 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 NCT05833178, which also lists 2 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 15 Jun 2023.