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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anemia
• Intervention / Treatment: Device: Small Phlebotomy Tube Group; Device: Standard Phlebotomy Tube Group

• Study Type: Interventional
• Enrollment (Estimated): 688
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Javier Barreda Garcia, MD; Phone Number: 713-500-6828; Email: Javier.BarredaGarcia@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Javier Barreda Garcia, MD; Phone Number: 713-500-6828; Email: Javier.BarredaGarcia@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Javier Barreda Garcia, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2023
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: February 10, 2023
• First Submitted That Met QC Criteria: February 25, 2023
• First Posted (Actual): March 2, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Blood transfusion
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: HSC-MS-22-1045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No