Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00413816
Status:
UNKNOWN
Last Update Posted:
2006-12-20
First Post:
2006-12-19
Brief Title:
The Israeli Trigger for Blood Transfusions in the ICU
Sponsor:
Rabin Medical Center
Organization:
Rabin Medical Center
Study Overview
Official Title:
A Multicenter Study of Anemia in the ICU Patient Determination of the Israeli Trigger and Post ICU Course
Status:
UNKNOWN
Status Verified Date:
2006-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 187 vs 233 P 11 and significant decreases in mortality among patients who were less acutely ill 87 vs 161 P 03 in the group treated using a transfusion trigger reflected in a hemoglobin level of 70 gdL 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 gdL 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 gL 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 13gdl in males and 11 gdl in females while 24 of males and 279 of females had a hemoglobin level 9 gdl 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
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 13gdl in males and 11 gdl in females while 24 of males and 279 of females had a hemoglobin level 9 gdl 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None