<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04460625</url>
  </required_header>
  <id_info>
    <org_study_id>2020-09</org_study_id>
    <nct_id>NCT04460625</nct_id>
  </id_info>
  <brief_title>Effect of Blood Group on the Survival Status of Intensive Care Patients</brief_title>
  <official_title>Investigation of the Effect of Different Blood Groups on the Survival of Intensive Care Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zonguldak Bulent Ecevit University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zonguldak Bulent Ecevit University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The research was planned to determine the effect of different blood groups on the 90-day&#xD;
      survival of intensive care patients who were treated and maintained for the first time in the&#xD;
      intensive care unit.&#xD;
&#xD;
      The research is a retrospective descriptive research. For the first time in an intensive care&#xD;
      unit aged 18 and over, between January 1, 2014 and December 31, 2019, of a state and a&#xD;
      university hospital in the Western Black Sea Region, in intensive care units (both medical&#xD;
      and surgical patients), All the patients, who were hospitalized in the intensive care unit&#xD;
      for at least 24 hours, were discharged from the intensive care unit for 90 days and less, and&#xD;
      all the information in the Patient Information Form can be accessed from the automation&#xD;
      system.&#xD;
&#xD;
      The research will be conducted between 01.04.2020-01.07.2020 by collecting the necessary data&#xD;
      within the 'Patient Information Form' of the patients from the information processing unit of&#xD;
      the hospitals where the research will be conducted.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intensive care units; They are units where advanced technological tools and equipment are&#xD;
      used to provide the highest level of benefit to life-threatened patients, and physicians and&#xD;
      nurses specializing in the treatment and care of patients are involved. Intensive care&#xD;
      patients; '' To prevent patients who are at risk due to physiological decompensation and&#xD;
      patients who are physically physiologically fluctuating, need a treatment to be carried out&#xD;
      with the harmony between physician and nurse to ensure survival, the application of this&#xD;
      treatment without showing waves, especially details and care, and unexpected adverse events.&#xD;
      and patients who require continuous monitoring to provide immediate intervention by the&#xD;
      intensive care team. Intensive care patients, as can be understood from the definition, are&#xD;
      the patients whose general conditions change rapidly due to the presence of a&#xD;
      life-threatening condition, due to the impact of several systems that require close&#xD;
      monitoring and control vital functions.&#xD;
&#xD;
      Respiratory, cardiovascular, neurological, etc. Many conditions, such as chronic diseases,&#xD;
      genetic, individual and environmental factors, of patients who are in danger of life due to&#xD;
      many important health problems can affect the prognosis of the patients. In addition to these&#xD;
      factors, although there is insufficient evidence, blood groups are reported to be effective&#xD;
      in the survival of intensive care patients. Whatever the underlying situation is, the most&#xD;
      important thing is undoubtedly the blood for the maintenance of a healthy life. It is known&#xD;
      to affect human health in many cases, from the amount of blood circulating in the vein to the&#xD;
      structure of blood cells.&#xD;
&#xD;
      It was found for the first time in the years of 1899 and 1900 that human blood differs from&#xD;
      individual to individual due to some physiological features. These different blood groups&#xD;
      discovered are A, B and AB. Later, with the discovery of the Rh factor along with the O&#xD;
      (zero) blood group, studies on the effects and differences of blood groups on humans have&#xD;
      increased rapidly. Today, studies on the relationship between blood groups and diseases are&#xD;
      ongoing.&#xD;
&#xD;
      As a result of some studies; It has been determined that the AB blood group plays a role as a&#xD;
      risk factor in both venous thromboembolism and coronary artery disease. The risk of both&#xD;
      arterial and venous thrombotic events in the AB blood group There is evidence that it has&#xD;
      high levels of vonWillebrand factor (vWF) and factor VIII. Depending on the limitation of&#xD;
      mobilization in intensive care patients, it may increase the negative effect of the blood&#xD;
      group on the patient compared to the patients hospitalized in other clinics. However, in&#xD;
      patient groups with a high risk of bleeding, this may provide additional benefit for patients&#xD;
      with AB blood group with higher levels of vonWillebrand factor (vWF) and factor VIII. In&#xD;
      their research, Franchini et al. Reported that bleeding rate increased significantly in&#xD;
      patients with O blood group, especially in surgical procedures with high risk of blood loss.&#xD;
      Therefore, it has been observed that patients with AB blood group are more likely to survive&#xD;
      after major heart surgery and this situation is explained in relation to the decrease in the&#xD;
      number of blood transfusions. The results of metaanalysis study of Dentali et al. Also&#xD;
      pointed out that having an O blood group in terms of bleeding may be an important genetic&#xD;
      factor. It is important that the intensive care nurse includes this information in patient&#xD;
      care.&#xD;
&#xD;
      In a study conducted to determine the link between ABO blood group, lipid profiles and&#xD;
      coronary artery disease and to determine the effect size of the link, patients in the A blood&#xD;
      group were found to have higher total cholesterol rates while lower LDL rates. Jiang et al;&#xD;
      They found that ABO blood groups were not associated with age, gender, and blood pressure in&#xD;
      stable coronary artery patients undergoing percutaneous coronary intervention, but blood&#xD;
      groups were associated with 2-year cardiac death.&#xD;
&#xD;
      Although it is known that genetic diversity affecting the prognosis of patients is a factor&#xD;
      in determining survival after being taken into intensive care, it can be difficult and costly&#xD;
      to evaluate in a short time in clinical practice. Also, to predict the prognosis of critical&#xD;
      patients in intensive care units today. it is still very difficult. In this context,&#xD;
      individualized medicine; It can provide a better understanding of patients' risks arising&#xD;
      from genetic, environmental and social factors and better planning of the results of&#xD;
      treatment. At the onset of critical illness, knowing all possible risk factors to effectively&#xD;
      manage patients creates a chance to achieve more successful treatment and care outcomes. more&#xD;
      difficult to determine the effect on survival of genetic diversity, although there is nothing&#xD;
      for a long time consuming and costly, ABO blood group of the survival effect according to the&#xD;
      risk classification system, the addition of both easier, additional benefits to the patient&#xD;
      to be quickly and cost-free by the Ministry of Health in sağlayabilir. Türkiye APACHE II&#xD;
      (Acute Physiology and Chronic Health Evaluation) is the most commonly used scale to calculate&#xD;
      the expected mortality rate according to the severity of the disease that is approved and&#xD;
      admitted to intensive care.&#xD;
&#xD;
      The relationship between patients' blood groups and mortality is thought to exist as a result&#xD;
      of research. In the research of Slade et al; After the patients were admitted to the&#xD;
      intensive care unit, the relationship between blood groups and mortality was evaluated in the&#xD;
      90-day period; It has been determined that patients with intensive care with AB blood group&#xD;
      have a higher 90-day survival time compared to other blood group patients. In line with this&#xD;
      result, there is a need for studies for the risk assessment scales and the addition of the&#xD;
      blood group factor for intensive care patients.&#xD;
&#xD;
      Quality nursing care is an important factor affecting the prognosis of patients. It is&#xD;
      predicted that the application of individualized patient care will positively affect the&#xD;
      physiological, psychological and social health of the patient. Nurses are healthcare&#xD;
      professionals who are in key condition next to the patient in any case in intensive care&#xD;
      units. Higher quality care of nurses at the center of many interventions in the intensive&#xD;
      care unit has been associated with improved patient outcomes, including mortality. In line&#xD;
      with this information, the research was planned to determine the effect of different blood&#xD;
      groups on the 90-day survival of intensive care patients who were treated and maintained for&#xD;
      the first time in the intensive care unit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Actual">February 7, 2022</completion_date>
  <primary_completion_date type="Actual">February 5, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Examination of the correlation between blood group of patients and rh factor and secondary complication development during admission to intensive care units</measure>
    <time_frame>Whether or not complications develop within 90 days of admission to patients in intensive care unit</time_frame>
    <description>At the onset of critical illness,knowing all possible risk factors to effectively manage patients creates a chance to achieve more successful treatment and care outcomes.Although it is more difficult time consuming and costly to determine the effect of genetic diversity on survival,the addition of ABO blood groups to the risk classification system according to the effect on survival may also provide additional benefits to the patient as it will be easier,faster and inexpensive.It is observed that this factor is missing in the mortality risk diagnosis forms used during the intensive care hospitalization currently used.Patients with 0 blood group,in which the AB blood group plays a role in both venous thromboembolism and coronary artery disease as a risk factor and their tendency to clot;It has been reported that the bleeding rate increases significantly,especially in surgical procedures with high risk of blood loss.If it is considered that the procedures applied in intensive care ünit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Examining the correlation between the patient's blood group and rh factor and mortality in patients</measure>
    <time_frame>Mortality rates will be checked within 90 days from the patients' admission to intensive care unit.</time_frame>
    <description>The relationship between patients' blood groups and mortality is thought to exist as a result of research. In a research; After the patients were admitted to the intensive care unit, the relationship between blood groups and mortality was evaluated in the 90-day period; It has been determined that patients with intensive care with AB blood group have a higher 90-day survival time compared to other blood group patients. In line with this result, there is a need for studies for the risk assessment scales and the addition of the blood group factor for intensive care patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Examination of the correlation between patients 'invasive mechanical ventilation status and duration, and patients' 90-day survival</measure>
    <time_frame>90 days</time_frame>
    <description>Patients receiving invasive mechanical ventilator support is a risk factor for morbidity and mortality. Because, patients who receive mechanical ventilation support increase the risk of complications compared to other patients. In the research, the status and duration of patients receiving mechanical ventilator support will be recorded with the patient information form and it is planned to look at the relationship between the appropriate statistical methods at the end of the research.</description>
  </secondary_outcome>
  <enrollment type="Actual">3114</enrollment>
  <condition>Critical Illness</condition>
  <condition>Nurse's Role</condition>
  <condition>Risk Factor</condition>
  <condition>Prognosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Zonguldak Atatürk State Hospital located in the Western Black Sea Region, were treated&#xD;
        between January 1, 2014 and 31.12.2019 in intensive care units (both medical and surgical&#xD;
        patients). The number of patients admitted to the intensive care units was determined from&#xD;
        the information processing unit of the hospitals and determined as 4.120. These patients&#xD;
        will form the universe of the research. Of these patients; All patients who are&#xD;
        hospitalized for the first time in the intensive care unit, who are in the intensive care&#xD;
        unit for at least 24 hours, who are discharged from the intensive care unit for 90 days and&#xD;
        less, all information in the data collection form, 18 years of age and over, will be the&#xD;
        sample group.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being 18 or older&#xD;
&#xD;
          -  Being in the intensive care unit for the first time,&#xD;
&#xD;
          -  To stay in the intensive care unit for at least 24 hours.&#xD;
&#xD;
          -  Being discharged from the intensive care unit in 90 days and less&#xD;
&#xD;
          -  All information in the Patient Information Form can be accessed from the automation&#xD;
             system.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Being under the age of 18&#xD;
&#xD;
          -  Having previously slept in the intensive care unit&#xD;
&#xD;
          -  Intensive care hospitalization has ended in less than 24 hours.&#xD;
&#xD;
          -  Staying in the intensive care unit for more than 90 days&#xD;
&#xD;
          -  Failure to reach all questions in the Patient Information form from the automation&#xD;
             system&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sibel Köstekli</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zonguldak Bülent Ecevit University Faculty of Health Sciences Nursing Department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zonguldak Atatürk State Hospital</name>
      <address>
        <city>Zonguldak</city>
        <state>Meşrutiyet</state>
        <zip>67100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>February 7, 2022</last_update_submitted>
  <last_update_submitted_qc>February 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zonguldak Bulent Ecevit University</investigator_affiliation>
    <investigator_full_name>Sibel Köstekli</investigator_full_name>
    <investigator_title>Zonguldak Bülent Ecevit University Faculty of Health Sciences</investigator_title>
  </responsible_party>
  <keyword>intensive care</keyword>
  <keyword>intensive care nursing</keyword>
  <keyword>critical patient</keyword>
  <keyword>blood group</keyword>
  <keyword>survival</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04460625
org study id: 2020-09
nct id: NCT04460625
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The research was planned to determine the effect of different blood groups on the 90-day
      survival of intensive care patients who were treated and maintained for the first time in the
      intensive care unit.

      The research is a retrospective descriptive research. For the first time in an intensive care
      unit aged 18 and over, between January 1, 2014 and December 31, 2019, of a state and a
      university hospital in the Western Black Sea Region, in intensive care units (both medical
      and surgical patients), All the patients, who were hospitalized in the intensive care unit
      for at least 24 hours, were discharged from the intensive care unit for 90 days and less, and
      all the information in the Patient Information Form can be accessed from the automation
      system.

      The research will be conducted between 01.04.2020-01.07.2020 by collecting the necessary data
      within the 'Patient Information Form' of the patients from the information processing unit of
      the hospitals where the research will be conducted.
Intensive care units; They are units where advanced technological tools and equipment are
      used to provide the highest level of benefit to life-threatened patients, and physicians and
      nurses specializing in the treatment and care of patients are involved. Intensive care
      patients; '' To prevent patients who are at risk due to physiological decompensation and
      patients who are physically physiologically fluctuating, need a treatment to be carried out
      with the harmony between physician and nurse to ensure survival, the application of this
      treatment without showing waves, especially details and care, and unexpected adverse events.
      and patients who require continuous monitoring to provide immediate intervention by the
      intensive care team. Intensive care patients, as can be understood from the definition, are
      the patients whose general conditions change rapidly due to the presence of a
      life-threatening condition, due to the impact of several systems that require close
      monitoring and control vital functions.

      Respiratory, cardiovascular, neurological, etc. Many conditions, such as chronic diseases,
      genetic, individual and environmental factors, of patients who are in danger of life due to
      many important health problems can affect the prognosis of the patients. In addition to these
      factors, although there is insufficient evidence, blood groups are reported to be effective
      in the survival of intensive care patients. Whatever the underlying situation is, the most
      important thing is undoubtedly the blood for the maintenance of a healthy life. It is known
      to affect human health in many cases, from the amount of blood circulating in the vein to the
      structure of blood cells.

      It was found for the first time in the years of 1899 and 1900 that human blood differs from
      individual to individual due to some physiological features. These different blood groups
      discovered are A, B and AB. Later, with the discovery of the Rh factor along with the O
      (zero) blood group, studies on the effects and differences of blood groups on humans have
      increased rapidly. Today, studies on the relationship between blood groups and diseases are
      ongoing.

      As a result of some studies; It has been determined that the AB blood group plays a role as a
      risk factor in both venous thromboembolism and coronary artery disease. The risk of both
      arterial and venous thrombotic events in the AB blood group There is evidence that it has
      high levels of vonWillebrand factor (vWF) and factor VIII. Depending on the limitation of
      mobilization in intensive care patients, it may increase the negative effect of the blood
      group on the patient compared to the patients hospitalized in other clinics. However, in
      patient groups with a high risk of bleeding, this may provide additional benefit for patients
      with AB blood group with higher levels of vonWillebrand factor (vWF) and factor VIII. In
      their research, Franchini et al. Reported that bleeding rate increased significantly in
      patients with O blood group, especially in surgical procedures with high risk of blood loss.
      Therefore, it has been observed that patients with AB blood group are more likely to survive
      after major heart surgery and this situation is explained in relation to the decrease in the
      number of blood transfusions. The results of metaanalysis study of Dentali et al. Also
      pointed out that having an O blood group in terms of bleeding may be an important genetic
      factor. It is important that the intensive care nurse includes this information in patient
      care.

      In a study conducted to determine the link between ABO blood group, lipid profiles and
      coronary artery disease and to determine the effect size of the link, patients in the A blood
      group were found to have higher total cholesterol rates while lower LDL rates. Jiang et al;
      They found that ABO blood groups were not associated with age, gender, and blood pressure in
      stable coronary artery patients undergoing percutaneous coronary intervention, but blood
      groups were associated with 2-year cardiac death.

      Although it is known that genetic diversity affecting the prognosis of patients is a factor
      in determining survival after being taken into intensive care, it can be difficult and costly
      to evaluate in a short time in clinical practice. Also, to predict the prognosis of critical
      patients in intensive care units today. it is still very difficult. In this context,
      individualized medicine; It can provide a better understanding of patients' risks arising
      from genetic, environmental and social factors and better planning of the results of
      treatment. At the onset of critical illness, knowing all possible risk factors to effectively
      manage patients creates a chance to achieve more successful treatment and care outcomes. more
      difficult to determine the effect on survival of genetic diversity, although there is nothing
      for a long time consuming and costly, ABO blood group of the survival effect according to the
      risk classification system, the addition of both easier, additional benefits to the patient
      to be quickly and cost-free by the Ministry of Health in sağlayabilir. Türkiye APACHE II
      (Acute Physiology and Chronic Health Evaluation) is the most commonly used scale to calculate
      the expected mortality rate according to the severity of the disease that is approved and
      admitted to intensive care.

      The relationship between patients' blood groups and mortality is thought to exist as a result
      of research. In the research of Slade et al; After the patients were admitted to the
      intensive care unit, the relationship between blood groups and mortality was evaluated in the
      90-day period; It has been determined that patients with intensive care with AB blood group
      have a higher 90-day survival time compared to other blood group patients. In line with this
      result, there is a need for studies for the risk assessment scales and the addition of the
      blood group factor for intensive care patients.

      Quality nursing care is an important factor affecting the prognosis of patients. It is
      predicted that the application of individualized patient care will positively affect the
      physiological, psychological and social health of the patient. Nurses are healthcare
      professionals who are in key condition next to the patient in any case in intensive care
      units. Higher quality care of nurses at the center of many interventions in the intensive
      care unit has been associated with improved patient outcomes, including mortality. In line
      with this information, the research was planned to determine the effect of different blood
      groups on the 90-day survival of intensive care patients who were treated and maintained for
      the first time in the intensive care unit.
observational model: Cohort
time perspective: Retrospective
measure: Examination of the correlation between blood group of patients and rh factor and secondary complication development during admission to intensive care units
time frame: Whether or not complications develop within 90 days of admission to patients in intensive care unit
description: At the onset of critical illness,knowing all possible risk factors to effectively manage patients creates a chance to achieve more successful treatment and care outcomes.Although it is more difficult time consuming and costly to determine the effect of genetic diversity on survival,the addition of ABO blood groups to the risk classification system according to the effect on survival may also provide additional benefits to the patient as it will be easier,faster and inexpensive.It is observed that this factor is missing in the mortality risk diagnosis forms used during the intensive care hospitalization currently used.Patients with 0 blood group,in which the AB blood group plays a role in both venous thromboembolism and coronary artery disease as a risk factor and their tendency to clot;It has been reported that the bleeding rate increases significantly,especially in surgical procedures with high risk of blood loss.If it is considered that the procedures applied in intensive care ünit.
measure: Examining the correlation between the patient's blood group and rh factor and mortality in patients
time frame: Mortality rates will be checked within 90 days from the patients' admission to intensive care unit.
description: The relationship between patients' blood groups and mortality is thought to exist as a result of research. In a research; After the patients were admitted to the intensive care unit, the relationship between blood groups and mortality was evaluated in the 90-day period; It has been determined that patients with intensive care with AB blood group have a higher 90-day survival time compared to other blood group patients. In line with this result, there is a need for studies for the risk assessment scales and the addition of the blood group factor for intensive care patients.
measure: Examination of the correlation between patients 'invasive mechanical ventilation status and duration, and patients' 90-day survival
time frame: 90 days
description: Patients receiving invasive mechanical ventilator support is a risk factor for morbidity and mortality. Because, patients who receive mechanical ventilation support increase the risk of complications compared to other patients. In the research, the status and duration of patients receiving mechanical ventilator support will be recorded with the patient information form and it is planned to look at the relationship between the appropriate statistical methods at the end of the research.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sibel Köstekli
role: Principal Investigator
affiliation: Zonguldak Bülent Ecevit University Faculty of Health Sciences Nursing Department
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Zonguldak Bulent Ecevit University
investigator full name: Sibel Köstekli
investigator title: Zonguldak Bülent Ecevit University Faculty of Health Sciences
mesh term: Critical Illness
sharing ipd: No