Anemia
Conditions
Keywords
Blood transfusion
Brief summary
The purpose of this study is to evaluate the effectiveness of small phlebotomy tubes to reduce RBC transfusions in medical intensive care unit (ICU) and Intermediate care unit (IMU) patients with low hemoglobin compared with standard size tubes, to compare the intervention and the control groups in regards to: ICU length of stay (LOS), ICU mortality, hospital LOS, and hospital mortality and to assess the acceptability of small phlebotomy tubes in adult ICU and IMU patients.
Interventions
DEVICESmall Phlebotomy Tube Group
In the small tubes group, the recommended blood volumes are 0.5 mL for hematology and single chemistry tests, and 1 mL when multiple chemistry tests are needed. A, a "non-formulary medication" order will be placed in the electronic medical record to alert nurses to collect blood in small tubes. Participants will continue to use small tubes anytime they are in the ICU or IMU.
DEVICEStandard Phlebotomy Tube Group
In the standard tubes group, the recommended blood volumes are 4.0 mL for hematology and 3.0 for chemistry tests.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Admission to the medical ICU or IMU. * Hemoglobin less than 10 g/dL.
Exclusion criteria
* Clinical bleeding. Defined as any bleeding needing an intervention. An intervention could be an increase in the frequency of hemoglobin monitoring, a transfusion, a procedure, or a consultation intended to prevent or treat bleeding. * Hemolytic disorder (e.g. sickle cell disease, hereditary spherocytosis, autoimmune hemolytic anemia). * Bone marrow disorder (e.g. aplastic anemia, leukemia, marrow infiltration disorder, chemotherapy within the last 8 weeks). * Jehovah's Witnesses. * Patient is comfort care measures only. * Refractory shock: Mean arterial blood pressure below 65 mmHg despite maximal doses of 3 vasopressors. Maximal dose of vasopressors are as follows: Norepinephrine 70 mcg/min; vasopressin 0.03 units/min; epinephrine 35 mcg/min; dopamine 20 mcg/kg/min; phenylephrine 350 mcg/min. * Severe acidosis: pH below 7 in more than one arterial blood gas in the past 24 hours, in the absence of diabetic ketoacidosis. * Surgical admission diagnosis. * Pregnancy. * Current prisoner
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants that receive a red blood cell (RBC) transfusion during hospitalization | up to 30 days after randomization |
Secondary
| Measure | Time frame |
|---|---|
| Number of RBC units transfused during hospitalization | up to 30 days after randomization |
| Length of stay in ICU | completion of study (up to 90 days from enrollment) |
| Number of participants that died while in ICU | completion of study (up to 90 days from enrollment) |
| Length of stay in hospital | completion of study (up to 90 days from enrollment) |
| Number of participants that died while in hospital | completion of study (up to 90 days from enrollment) |
| Acceptability of small tubes as assessed by determining the number of patients that switch from small tubes to standard tubes | up to 30 days after randomization |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJavier Barreda Garcia, MD
The University of Texas Health Science Center, Houston
Outcome results
None listed