Clinical trial NCT05750654: Effectiveness of Small Phlebotomy Tubes in Reducing Blood Transfusions in Adult Medical Intensive Care Unit and Intermediate Care Unit Patients With Anemia
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anemia
Keywords: Blood transfusion
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 688
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants that receive a red blood cell (RBC) transfusion during hospitalization
timeFrame: up to 30 days after randomization
Secondary outcomes:
measure: Number of RBC units transfused during hospitalization
timeFrame: up to 30 days after randomization
measure: Length of stay in ICU
timeFrame: completion of study (up to 90 days from enrollment)
measure: Number of participants that died while in ICU
timeFrame: completion of study (up to 90 days from enrollment)
measure: Length of stay in hospital
timeFrame: completion of study (up to 90 days from enrollment)
measure: Number of participants that died while in hospital
timeFrame: completion of study (up to 90 days from enrollment)
measure: Acceptability of small tubes as assessed by determining the number of patients that switch from small tubes to standard tubes
timeFrame: up to 30 days after randomization
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Javier Barreda Garcia, MD
role: PRINCIPAL_INVESTIGATOR
References: