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

The University of Texas System (UT)

Status: Enrolling

Conditions: Anemia

Treatments: Device: Standard Phlebotomy Tube Group; Device: Small Phlebotomy Tube Group

Study type: Interventional

Funder types: Other

Identifiers

NCT05750654

HSC-MS-22-1045

Details and patient eligibility

About

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.

Enrollment: 688 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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688 participants in 2 patient groups

Small Tube Group

Experimental group

Treatment:

Device: Small Phlebotomy Tube Group

Standard Tube Group

Active Comparator group

Treatment:

Device: Standard Phlebotomy Tube Group