Back to resultsEffectiveness of Small Phlebotomy Tubes in Reducing Blood Transfusions in Adult Medical Intensive Care Unit and Intermediate Care Unit Patients With Anemia
Primary Purpose
Anemia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Small Phlebotomy Tube Group
Standard Phlebotomy Tube Group
Sponsored by
About this trial
This is an interventional prevention trial for Anemia focused on measuring Blood transfusion
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
Sites / Locations
- The University of Texas Health Science Center at HoustonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Small Tube Group
Standard Tube Group
Arm Description
Outcomes
Primary Outcome Measures
Number of participants that receive a red blood cell (RBC) transfusion during hospitalization
Secondary Outcome Measures
Number of RBC units transfused during hospitalization
Length of stay in ICU
Number of participants that died while in ICU
Length of stay in hospital
Number of participants that died while in hospital
Acceptability of small tubes as assessed by determining the number of patients that switch from small tubes to standard tubes
Full Information
NCT ID
NCT05750654
First Posted
February 10, 2023
Last Updated
July 26, 2023
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT05750654
Brief Title
Effectiveness of Small Phlebotomy Tubes in Reducing Blood Transfusions in Adult Medical Intensive Care Unit and Intermediate Care Unit Patients With Anemia
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 24, 2023 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
Blood transfusion
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
688 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Small Tube Group
Arm Type
Experimental
Arm Title
Standard Tube Group
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Small Phlebotomy Tube Group
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Standard Phlebotomy Tube Group
Intervention Description
In the standard tubes group, the recommended blood volumes are 4.0 mL for hematology and 3.0 for chemistry tests.
Primary Outcome Measure Information:
Title
Number of participants that receive a red blood cell (RBC) transfusion during hospitalization
Time Frame
up to 30 days after randomization
Secondary Outcome Measure Information:
Title
Number of RBC units transfused during hospitalization
Time Frame
up to 30 days after randomization
Title
Length of stay in ICU
Time Frame
completion of study (up to 90 days from enrollment)
Title
Number of participants that died while in ICU
Time Frame
completion of study (up to 90 days from enrollment)
Title
Length of stay in hospital
Time Frame
completion of study (up to 90 days from enrollment)
Title
Number of participants that died while in hospital
Time Frame
completion of study (up to 90 days from enrollment)
Title
Acceptability of small tubes as assessed by determining the number of patients that switch from small tubes to standard tubes
Time Frame
up to 30 days after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Javier Barreda Garcia, MD
Phone
713-500-6828
Email
Javier.BarredaGarcia@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Barreda Garcia, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Barreda Garcia, MD
Phone
713-500-6828
Email
Javier.BarredaGarcia@uth.tmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Small Phlebotomy Tubes in Reducing Blood Transfusions in Adult Medical Intensive Care Unit and Intermediate Care Unit Patients With Anemia
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