AnemiaNCT00413816
The Israeli Trigger for Blood Transfusions in the ICU
An observational study of Anemia, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The purpose of the study is to determine the trigger for blood transfusions in Israeli ICU patients and the possible effects of anemia on the post ICU discharge course. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anemia
- How many people
- 500 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2006to Dec 2006
- 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
Who may be able to join
- all patients admitted to ICU
Who cannot join
- age < 18 years
- > 20% full thickness burns
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Study of Anemia in the ICU Patient: Determination of the Israeli Trigger and Post ICU Course
The purpose of the study is to determine the trigger for blood transfusions in Israeli ICU patients and the possible effects of anemia on the post ICU discharge course.
Read the detailed description
Anemia is a common problem in critically ill patients admitted to intensive care units (ICUs). The etiology is multifactorial and includes sepsis, overt or occult blood loss (including frequent blood sampling), decreased production of endogenous erythropoietin, and immune-associated functional iron deficiency. In the only large randomized trial addressing the issue of transfusion triggers in the perioperative and critical care setting, the Canadian Transfusion Requirements in Critical Care (TRICC) study documented an overall non significant trend toward decreased 30-day mortality (18.7% vs. 23.3%, P = .11) and significant decreases in mortality among patients who were less acutely ill (8.7% vs. 16.1%, P = .03) in the group treated using a transfusion trigger reflected in a hemoglobin level of 7.0 g/dL compared with a more liberal transfusion group that received 54% more red blood cell (RBC) transfusions. This data suggests that many critically ill patients can tolerate hemoglobin levels as low as 7 g/dL and that a "liberal" RBC transfusion strategy may in fact lead to worse clinical outcomes. Evidence-based transfusion guidelines for critically ill and perioperative patients recommend RBC transfusion when the hemoglobin concentration is less than 7 g/L and transfusion avoidance at values greater than 10 g/ L .
The restrictive blood transfusion policy results in many patients being discharged anemic from the ICU. In a recent Scottish study, 87% of ICU survivors were discharged anemic (defined as a hemoglobin level < 13g/dl in males and 11 g/dl in females), while 24% of males and 27.9% of females had a hemoglobin level < 9 g/dl. While studies have shown that a restrictive blood transfusion policy does not adversely affect the 30- or 60-day mortality , there is no information regarding the effect of anemia on immediate and long term morbidity of ICU survivors. This may be important as anemia has been shown to decrease functional status and quality of life, while treating anemia may improve functional status and decrease morbidity. In addition, it is not known how many of these patients receive blood transfusions following ICU discharge.
In Israel, there are no national guidelines for the administration of red blood cells in the ICU and the national "trigger" is unknown.
- Study Rationale The determination of the ICU "trigger" will determine if the ICU is performing according to presently accepted standards. Determining the effect of anemia after ICU discharge may allow for targeted interventions in particular groups of patients which may improve recovery rates.
- This study is a non-intervention, observational, multi- center study.
- All ICU patients over 18 years of age will be included.
- Demographic data will be collected on admission of the patient to the ICU
- Daily hemoglobin levels (routine morning hemoglobin) and the hemoglobin level which triggered the blood transfusion (if different from the morning level) will be recorded and the number and indication for red blood cell transfusions noted.
- Hemoglobin level will be noted on discharge from the ICU.
- Hemoglobin levels, length of hospital stay and occurrence of complications in the post-ICU period will be noted.
- Conditions
- Anemia
- Keywords
- Anemia, Critically ill
- Medical subject headings
- Anemia, Critical Illness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2006 (estimated)
- Study startOct 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Defined population
- Time perspective
- Other
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Jonathan Cohen, Principal investigator, Rabin Medical Center, Campus Beilinson, Petah Tikva , Israel, 49100
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413816
- Sponsor's protocol ID
- 004152
- Status last verified
- Oct 2006
- First submitted
- 19 Dec 2006
- Last updated
- 20 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study of Anemia in the ICU Patient: Determination of the Israeli Trigger and Post ICU Course
- ClinicalTrials.gov ID
- NCT00413816
- Acronym / sponsor ID
- 004152
- Conditions
- Anemia
- Keywords
- Anemia, Critically ill
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Oct 2006
- Study completion
- Dec 2006
- First posted
- 20 Dec 2006 (estimated)
- 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.
The purpose of the study is to determine the trigger for blood transfusions in Israeli ICU patients and the possible effects of anemia on the post ICU discharge course.
Detailed description
Anemia is a common problem in critically ill patients admitted to intensive care units (ICUs). The etiology is multifactorial and includes sepsis, overt or occult blood loss (including frequent blood sampling), decreased production of endogenous erythropoietin, and immune-associated functional iron deficiency. In the only large randomized trial addressing the issue of transfusion triggers in the perioperative and critical care setting, the Canadian Transfusion Requirements in Critical Care (TRICC) study documented an overall non significant trend toward decreased 30-day mortality (18.7% vs. 23.3%, P = .11) and significant decreases in mortality among patients who were less acutely ill (8.7% vs. 16.1%, P = .03) in the group treated using a transfusion trigger reflected in a hemoglobin level of 7.0 g/dL compared with a more liberal transfusion group that received 54% more red blood cell (RBC) transfusions. This data suggests that many critically ill patients can tolerate hemoglobin levels as low as 7 g/dL and that a "liberal" RBC transfusion strategy may in fact lead to worse clinical outcomes. Evidence-based transfusion guidelines for critically ill and perioperative patients recommend RBC transfusion when the hemoglobin concentration is less than 7 g/L and transfusion avoidance at values greater than 10 g/ L .
The restrictive blood transfusion policy results in many patients being discharged anemic from the ICU. In a recent Scottish study, 87% of ICU survivors were discharged anemic (defined as a hemoglobin level < 13g/dl in males and 11 g/dl in females), while 24% of males and 27.9% of females had a hemoglobin level < 9 g/dl. While studies have shown that a restrictive blood transfusion policy does not adversely affect the 30- or 60-day mortality , there is no information regarding the effect of anemia on immediate and long term morbidity of ICU survivors. This may be important as anemia has been shown to decrease functional status and quality of life, while treating anemia may improve functional status and decrease morbidity. In addition, it is not known how many of these patients receive blood transfusions following ICU discharge.
In Israel, there are no national guidelines for the administration of red blood cells in the ICU and the national "trigger" is unknown.
- Study Rationale The determination of the ICU "trigger" will determine if the ICU is performing according to presently accepted standards. Determining the effect of anemia after ICU discharge may allow for targeted interventions in particular groups of patients which may improve recovery rates.
- This study is a non-intervention, observational, multi- center study.
- All ICU patients over 18 years of age will be included.
- Demographic data will be collected on admission of the patient to the ICU
- Daily hemoglobin levels (routine morning hemoglobin) and the hemoglobin level which triggered the blood transfusion (if different from the morning level) will be recorded and the number and indication for red blood cell transfusions noted.
- Hemoglobin level will be noted on discharge from the ICU.
- Hemoglobin levels, length of hospital stay and occurrence of complications in the post-ICU period will be noted.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients admitted to ICU
Key exclusion criteria (2 listed)
- age < 18 years
- > 20% full thickness burns
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2006.
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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.
Jonathan Cohen principal investigator
Rabin Medical Center, Campus Beilinson, Petah Tikva , Israel, 49100
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 Rabin Medical Center at 1 site in Israel.
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 20 Dec 2006. 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 Israel. 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 Jonathan Cohen, MD (+972-3-9376525, jonatanc@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 20 Dec 2006.