NCT05750654

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
688

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

July 24, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

September 10, 2025

Status Verified

August 1, 2025

Enrollment Period

2.5 years

First QC Date

February 10, 2023

Last Update Submit

September 9, 2025

Conditions

Anemia

Keywords

Blood transfusion

Outcome Measures

Primary Outcomes (1)

  • Number of participants that receive a red blood cell (RBC) transfusion during hospitalization

    up to 30 days after randomization

Secondary Outcomes (6)

  • 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)

  • +1 more secondary outcomes

Study Arms (2)

Small Tube Group

EXPERIMENTAL
Device: Small Phlebotomy Tube Group

Standard Tube Group

ACTIVE COMPARATOR
Device: Standard Phlebotomy Tube Group

Interventions

Small Phlebotomy Tube GroupDEVICE

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.

Small Tube Group
Standard Phlebotomy Tube GroupDEVICE

In the standard tubes group, the recommended blood volumes are 4.0 mL for hematology and 3.0 for chemistry tests.

Standard Tube Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admission to the medical ICU or IMU.
  • Hemoglobin less than 10 g/dL.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Javier Barreda Garcia, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Javier Barreda Garcia, MD

CONTACT

713-500-6828Javier.BarredaGarcia@uth.tmc.edu

Ibilola A Sanusi, MD

CONTACT

713-486-6153Ibilola.A.Sanusi@uth.tmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 10, 2023

First Posted

March 2, 2023

Study Start

July 24, 2023

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

September 10, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)