Anemia
Conditions
Keywords
blood transfusion
Brief summary
This study will evaluate the hypothesis that the use of pediatric size phlebotomy tubes reduces red blood cell (RBC) transfusions in adult intensive care unit (ICU) patients compared with the use of adult size tubes.
Interventions
DEVICEPediatric phlebotomy tubes
Use of pediatric size tubes for diagnostic blood collection.
DEVICEAdult phlebotomy tubes
Use of adult size tubes for diagnostic blood collection.
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
* New admission to the medical or transplant ICU at Memorial Hermann Hospital in Houston * ICU admission hemoglobin level of at least 7 g/dL. The ICU admission hemoglobin will be the most recent hemoglobin value available at the time of screening for inclusion in the study. * Randomization is expected within 12 hour of admission to the ICU
Exclusion criteria
* Clinical bleeding. Defined as menstrual bleeding, bleeding leading to a change in the frequency of hemoglobin monitoring or to an order for a medication, transfusion, procedure, or consultation intended to prevent or treat bleeding. * Known hemolytic disorder (e.g. sickle cell disease, hereditary spherocytosis, autoimmune hemolytic anemia) * Bone marrow disorder (e.g. aplastic anemia, 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 60 mmHg despite maximal doses of 3 vasopressors. Maximal dose of vasopressors are as follows: Norepinephrine 70 mcg/min; vasopressin 0.04 units/min; epinephrine 35 mcg/min; dopamine 20 mcg/kg/min; phenylephrine 350 mcg/min * Severe acidosis: potential of hydrogen (pH) below 7 in more than one arterial blood gas within 24 hours of ICU admission in the absence of diabetic ketoacidosis Surgical admission diagnosis * Pregnancy * Current prisoner
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Who Had Hemoglobin Less Than 7 g/dL or Red Blood Cell (RBC) Transfusion Order | from time of admission to intensive care unit (ICU) to 30 days after admission to ICU |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Change in Hemoglobin (g/dL/Day) While in the Intensive Care Unit (ICU) | from time of randomization to completion of study (up to 30 days after ICU admission) | This will be calculated as the most recent hemoglobin prior to randomization minus the last hemoglobin prior to ICU discharge, death, RBC transfusion, clinical bleeding, surgery, or change of clinical status to comfort measures, divided by the number of days (rounded to the nearest 0.5) between these two values (crude estimate). |
| Number of Participants Who Received a Red Blood Cell (RBC) Transfusion While in the ICU | completion of study (up to 30 days after ICU admission) | — |
| Number of Participants With at Least One Inadequate Blood Sample for Laboratory Analysis | completion of study (up to 30 days after ICU admission) | An inadequate blood sample is defined as any blood sample that requires recollection. |
| ICU Mortality | completion of study (up to 30 days after ICU admission) | — |
| Total Phlebotomy Volume | completion of study (up to 30 days after ICU admission) | The total phlebotomy volume is the total volume of blood collected over all days and is estimated based on the maximum volume needed for each type of blood test, as follows. In the pediatric tube arm, the volumes were 0.5 milliliters (mL) for hematology, 0.6 mL for chemistries (plasma), and 2.5 mL for coagulation tests. In the adult tube group, the volumes were 5.5 mL for hematology, 5 mL for chemistries (plasma), and 3.8 mL for coagulation. In both arms, tube volumes for lactate, immunology (serum), arterial blood gases, and blood cultures were 5 mL, 6.5 mL, 1 mL, and 10 mL, respectively. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pediatric Phlebotomy Tubes Use of pediatric size tubes for diagnostic blood collection. | 100 |
| Adult Phlebotomy Tubes Use of adult size tubes for diagnostic blood collection. | 100 |
| Total | 200 |
Baseline characteristics
| Characteristic | Total | Pediatric Phlebotomy Tubes | Adult Phlebotomy Tubes |
|---|---|---|---|
| Age, Continuous | 56.2 years STANDARD_DEVIATION 17.9 | 55 years STANDARD_DEVIATION 16.7 | 57 years STANDARD_DEVIATION 18.5 |
| APACHE II score | 22 score on a scale | 22.0 score on a scale | 23.0 score on a scale |
| Charlson comorbidity index | 3 score on a scale | 3.0 score on a scale | 4.0 score on a scale |
| Estimated blood volume | 4.77 liters | 4.9 liters | 4.6 liters |
| Hemoglobin concentration at intensive care unit (ICU) admission | 11.24 g/dL STANDARD_DEVIATION 2.35 | 11.4 g/dL STANDARD_DEVIATION 2.4 | 11.1 g/dL STANDARD_DEVIATION 2.3 |
| ICU Admission Diagnosis Acute Cardiovascular Disorder | 45 Participants | 21 Participants | 24 Participants |
| ICU Admission Diagnosis Acute renal failure | 71 Participants | 40 Participants | 31 Participants |
| ICU Admission Diagnosis Infection | 101 Participants | 55 Participants | 46 Participants |
| ICU Admission Diagnosis Metabolic disorder | 68 Participants | 32 Participants | 36 Participants |
| ICU Admission Diagnosis Non-infectious inflammatory disorder | 30 Participants | 19 Participants | 11 Participants |
| ICU Admission Diagnosis Other | 53 Participants | 22 Participants | 31 Participants |
| Number of participants who had invasive mechanical ventilation | 101 Participants | 50 Participants | 51 Participants |
| Number of participants with active malignancy | 10 Participants | 5 Participants | 5 Participants |
| Number of participants with chronic hemodialysis | 24 Participants | 12 Participants | 12 Participants |
| Number of participants with chronic kidney disease but no dialysis | 24 Participants | 13 Participants | 11 Participants |
| Number of participants with recent history of anemia | 92 Participants | 45 Participants | 47 Participants |
| Race/Ethnicity, Customized Black | 82 Participants | 36 Participants | 46 Participants |
| Race/Ethnicity, Customized Other | 41 Participants | 26 Participants | 15 Participants |
| Race/Ethnicity, Customized White | 77 Participants | 38 Participants | 39 Participants |
| Region of Enrollment United States | 200 Participants | 100 Participants | 100 Participants |
| Sex: Female, Male Female | 96 Participants | 45 Participants | 51 Participants |
| Sex: Female, Male Male | 104 Participants | 55 Participants | 49 Participants |
| Time from ICU admission to randomization | 5.64 hours | 5.3 hours | 5.7 hours |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 9 / 100 | 10 / 100 |
| other Total, other adverse events | 0 / 100 | 0 / 100 |
| serious Total, serious adverse events | 9 / 100 | 10 / 100 |
Outcome results
Primary
Number of Participants Who Had Hemoglobin Less Than 7 g/dL or Red Blood Cell (RBC) Transfusion Order
Time frame: from time of admission to intensive care unit (ICU) to 30 days after admission to ICU
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pediatric Phlebotomy Tubes | Number of Participants Who Had Hemoglobin Less Than 7 g/dL or Red Blood Cell (RBC) Transfusion Order | 6 Participants |
| Adult Phlebotomy Tubes | Number of Participants Who Had Hemoglobin Less Than 7 g/dL or Red Blood Cell (RBC) Transfusion Order | 11 Participants |
Secondary
ICU Mortality
Time frame: completion of study (up to 30 days after ICU admission)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pediatric Phlebotomy Tubes | ICU Mortality | 9 Participants |
| Adult Phlebotomy Tubes | ICU Mortality | 10 Participants |
Secondary
Number of Participants Who Received a Red Blood Cell (RBC) Transfusion While in the ICU
Time frame: completion of study (up to 30 days after ICU admission)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pediatric Phlebotomy Tubes | Number of Participants Who Received a Red Blood Cell (RBC) Transfusion While in the ICU | 4 Participants |
| Adult Phlebotomy Tubes | Number of Participants Who Received a Red Blood Cell (RBC) Transfusion While in the ICU | 9 Participants |
Secondary
Number of Participants With at Least One Inadequate Blood Sample for Laboratory Analysis
An inadequate blood sample is defined as any blood sample that requires recollection.
Time frame: completion of study (up to 30 days after ICU admission)
Population: This outcome data was not collected in the arm using adult phlebotomy tubes.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pediatric Phlebotomy Tubes | Number of Participants With at Least One Inadequate Blood Sample for Laboratory Analysis | 7 Participants |
Secondary
Rate of Change in Hemoglobin (g/dL/Day) While in the Intensive Care Unit (ICU)
This will be calculated as the most recent hemoglobin prior to randomization minus the last hemoglobin prior to ICU discharge, death, RBC transfusion, clinical bleeding, surgery, or change of clinical status to comfort measures, divided by the number of days (rounded to the nearest 0.5) between these two values (crude estimate).
Time frame: from time of randomization to completion of study (up to 30 days after ICU admission)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pediatric Phlebotomy Tubes | Rate of Change in Hemoglobin (g/dL/Day) While in the Intensive Care Unit (ICU) | -0.21 g/dL/day |
| Adult Phlebotomy Tubes | Rate of Change in Hemoglobin (g/dL/Day) While in the Intensive Care Unit (ICU) | -0.2 g/dL/day |
Secondary
Total Phlebotomy Volume
The total phlebotomy volume is the total volume of blood collected over all days and is estimated based on the maximum volume needed for each type of blood test, as follows. In the pediatric tube arm, the volumes were 0.5 milliliters (mL) for hematology, 0.6 mL for chemistries (plasma), and 2.5 mL for coagulation tests. In the adult tube group, the volumes were 5.5 mL for hematology, 5 mL for chemistries (plasma), and 3.8 mL for coagulation. In both arms, tube volumes for lactate, immunology (serum), arterial blood gases, and blood cultures were 5 mL, 6.5 mL, 1 mL, and 10 mL, respectively.
Time frame: completion of study (up to 30 days after ICU admission)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pediatric Phlebotomy Tubes | Total Phlebotomy Volume | 21 mL |
| Adult Phlebotomy Tubes | Total Phlebotomy Volume | 50 mL |