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Completed

NCT Number: NCT05750654

SHIIFT: Small Tubes to Halt Medical ICU/IMU Frequent Transfusions

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Small Phlebotomy Tube Group

Device

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

Device

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

Primary outcomes

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

    Time frame: up to 30 days after randomization

Secondary outcomes

  1. Number of RBC units transfused during hospitalization

    Time frame: up to 30 days after randomization

  2. Length of stay in ICU

    Time frame: completion of study (up to 90 days from enrollment)

  3. Number of participants that died while in ICU

    Time frame: completion of study (up to 90 days from enrollment)

  4. Length of stay in hospital

    Time frame: completion of study (up to 90 days from enrollment)

  5. Number of participants that died while in hospital

    Time frame: completion of study (up to 90 days from enrollment)

  6. 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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2023
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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