Effectiveness of Small Phlebotomy Tubes in Reducing Blood Transfusions in Adult Medical Intensive Care Unit and Intermediate Care Unit Patients With Anemia

Study Overview
=================
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.

Official Title
-----------------
Effectiveness of Small Phlebotomy Tubes in Reducing Blood Transfusions in Adult Medical Intensive Care Unit and Intermediate Care Unit Patients With Anemia: A Randomized Controlled Trial

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Device: Small Phlebotomy Tube Group
* Device: Standard Phlebotomy Tube Group


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Small Tube Group<br> | Device: Small Phlebotomy Tube Group<br>* 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.<br>|
| Active Comparator: Standard Tube Group<br> | Device: Standard Phlebotomy Tube Group<br>* In the standard tubes group, the recommended blood volumes are 4.0 mL for hematology and 3.0 for chemistry tests.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants that receive a red blood cell (RBC) transfusion during hospitalization |  | up to 30 days after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood transfusion