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Clinical Trials/NCT05750654
NCT05750654CompletedNot Applicable

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 University of Texas Health Science Center, Houston1 site in 1 country688 target enrollmentStarted: July 24, 2023Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
688
Locations
1
Primary Endpoint
Number of participants that receive a red blood cell (RBC) transfusion during hospitalization
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Standard Tube Group

Active Comparator

Intervention: Standard Phlebotomy Tube Group (Device)

Small Tube Group

Experimental

Intervention: Small Phlebotomy Tube Group (Device)

Outcomes

Primary Outcomes

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

Time Frame: up to 30 days after randomization

Secondary Outcomes

  • Length of stay in ICU(completion of study (up to 90 days from enrollment))
  • Number of RBC units transfused during hospitalization(up to 30 days after randomization)
  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Javier Barreda Garcia

Assistant Professor

The University of Texas Health Science Center, Houston

Study Sites (1)

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