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

Not Applicable

Recruiting

• Conditions: Anemia
• Interventions: Device: Standard Phlebotomy Tube Group; Device: Small Phlebotomy Tube Group

• Registration Number: NCT05750654
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-10
• Study First Submitted QC: 2023-02-25
• Study First Posted: 2023-03-02
• Status Verified: 2023-07
• Study Start: 2023-07-24
• Last Update Submitted: 2023-07-26
• Last Update Posted: 2023-07-27
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 688

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Tube Group	Standard Phlebotomy Tube Group	-
Small Tube Group	Small Phlebotomy Tube Group	-

Primary Outcome Measures

Name	Time	Method
Number of participants that receive a red blood cell (RBC) transfusion during hospitalization	up to 30 days after randomization

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States