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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05750654
• Other study ID #: HSC-MS-22-1045
• Status: Recruiting
• Phase: N/A
• Start date: July 24, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: July 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Javier Barreda Garcia, MD
• Phone: 713-500-6828
• Email: Javier.BarredaGarcia[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 688
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants that receive a red blood cell (RBC) transfusion during hospitalization		up to 30 days after randomization
Secondary	Number of RBC units transfused during hospitalization		up to 30 days after randomization
Secondary	Length of stay in ICU		completion of study (up to 90 days from enrollment)
Secondary	Number of participants that died while in ICU		completion of study (up to 90 days from enrollment)
Secondary	Length of stay in hospital		completion of study (up to 90 days from enrollment)
Secondary	Number of participants that died while in hospital		completion of study (up to 90 days from enrollment)
Secondary	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