Use of Pediatric Size Phlebotomy Tubes in Adult Critically Ill Patients to Reduce Red Blood Cell Transfusions

Study Overview
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Brief Summary
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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.

Official Title
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Pilot, Randomized Trial of the Use of Pediatric Size Phlebotomy Tubes in Adult Critically Ill Patients to Reduce Red Blood Cell Transfusions

Conditions
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Anemia

Intervention / Treatment
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* Device: Pediatric phlebotomy tubes
* Device: Adult phlebotomy tubes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pediatric phlebotomy tubes<br>Use of pediatric size tubes for diagnostic blood collection. | Device: Pediatric phlebotomy tubes<br>* Use of pediatric size tubes for diagnostic blood collection.<br>|
| Active Comparator: Adult phlebotomy tubes<br>Use of adult size tubes for diagnostic blood collection. | Device: Adult phlebotomy tubes<br>* Use of adult size tubes for diagnostic blood collection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | from time of randomization to completion of study (up to 30 days after ICU admission) | 
| 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 | An inadequate blood sample is defined as any blood sample that requires recollection. | completion of study (up to 30 days after ICU admission) | 
| ICU Mortality |  | completion of study (up to 30 days after ICU admission) | 
| 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. | completion of study (up to 30 days after ICU admission) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood transfusion