AnemiaNCT05750654
SHIIFT: Small Tubes to Halt Medical ICU/IMU Frequent Transfusions
A study testing Small Phlebotomy Tube Group and Standard Phlebotomy Tube Group in people with Anemia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- Small Phlebotomy Tube Group and Standard Phlebotomy Tube Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 688 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2023to 24 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission to the medical ICU or IMU.
- Hemoglobin less than 10 g/dL.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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
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.
- Conditions
- Anemia
- Being tested
- Small Phlebotomy Tube Group, Standard Phlebotomy Tube Group
- Keywords
- Blood transfusion
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Small Tube Group | Experimental | Not described Receives: Device: Small Phlebotomy Tube Group |
| Standard Tube Group | Active comparator | Not described Receives: Device: Standard Phlebotomy Tube Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that receive a red blood cell (RBC) transfusion during hospitalization
Measured: up to 30 days after randomization
Secondary outcomes (6)
Number of RBC units transfused during hospitalization
Measured: up to 30 days after randomization
Length of stay in ICU
Measured: completion of study (up to 90 days from enrollment)
Number of participants that died while in ICU
Measured: completion of study (up to 90 days from enrollment)
Length of stay in hospital
Measured: completion of study (up to 90 days from enrollment)
Number of participants that died while in hospital
Measured: 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
Measured: up to 30 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start24 Jul 2023
- Primary completion24 Feb 2026
- Study completion24 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 688 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Barreda Garcia, The University of Texas Health Science Center, Houston
- Investigators
- Javier Barreda Garcia, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750654
- Sponsor's protocol ID
- HSC-MS-22-1045
- Status last verified
- Jul 2026
- First submitted
- 10 Feb 2023
- Last updated
- 22 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05750654
- Acronym / sponsor ID
- HSC-MS-22-1045
- Conditions
- Anemia
- Keywords
- Blood transfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 688 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 24 Feb 2026 (actual)
- Study completion
- 24 Feb 2026 (actual)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Small Tube Group | Experimental | Device: Small Phlebotomy Tube Group |
| Standard Tube Group | Active comparator | Device: Standard Phlebotomy Tube Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Admission to the medical ICU or IMU.
- Hemoglobin less than 10 g/dL.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Small Phlebotomy Tube GroupIn 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. | Device | Small Tube Group |
| Standard Phlebotomy Tube GroupIn the standard tubes group, the recommended blood volumes are 4.0 mL for hematology and 3.0 for chemistry tests. | Device | Standard Tube Group |
Primary outcome
Number of participants that receive a red blood cell (RBC) transfusion during hospitalization
Time frame: up to 30 days after randomization
6 secondary outcomes
Number of RBC units transfused during hospitalization
Time frame: up to 30 days after randomization
Length of stay in ICU
Time frame: completion of study (up to 90 days from enrollment)
Number of participants that died while in ICU
Time frame: completion of study (up to 90 days from enrollment)
Length of stay in hospital
Time frame: completion of study (up to 90 days from enrollment)
Number of participants that died while in hospital
Time frame: 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
Time frame: up to 30 days after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Barreda Garcia, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Small Phlebotomy Tube Group and Standard Phlebotomy Tube Group in people with Anemia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that receive a red blood cell (RBC) transfusion during hospitalization (time frame: up to 30 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.