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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.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Jonathan Cohen, MD contact

+972-3-9376525

jonatanc@clalit.org.il

Israel1 site, 1 recruiting
  • Rabin Medical Center

    Petah Tikva, 49100

    Recruiting

Other trials in Israel

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.

  1. First posted20 Dec 2006 (estimated)
  2. Study startOct 2006
  3. Study completionDec 2006

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
Defined population
Time perspective
Other
Enrolment
500 participants
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

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.

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