Clinical trial NCT03286465: Use of Pediatric Size Phlebotomy Tubes in Adult Critically Ill Patients to Reduce Red Blood Cell Transfusions
Official title: Pilot, Randomized Trial of the Use of Pediatric Size Phlebotomy Tubes in Adult Critically Ill Patients to Reduce Red Blood Cell Transfusions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Keywords: blood transfusion
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2017-09-18
Enrollment: 200
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: This study will evaluate the hypothesis that the use of pediatric size phlebotomy tubes reduces red blood cell (RBC) transfusions in adult intensive care unit (ICU) patients compared with the use of adult size tubes.


Eligibility criteria: Inclusion Criteria:

* New admission to the medical or transplant ICU at Memorial Hermann Hospital in Houston
* ICU admission hemoglobin level of at least 7 g/dL. The ICU admission hemoglobin will be the most recent hemoglobin value available at the time of screening for inclusion in the study.
* Randomization is expected within 12 hour of admission to the ICU

Exclusion Criteria:

* Clinical bleeding. Defined as menstrual bleeding, bleeding leading to a change in the frequency of hemoglobin monitoring or to an order for a medication, transfusion, procedure, or consultation intended to prevent or treat bleeding.
* Known hemolytic disorder (e.g. sickle cell disease, hereditary spherocytosis, autoimmune hemolytic anemia)
* Bone marrow disorder (e.g. aplastic anemia, 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 60 mmHg despite maximal doses of 3 vasopressors. Maximal dose of vasopressors are as follows: Norepinephrine 70 mcg/min; vasopressin 0.04 units/min; epinephrine 35 mcg/min; dopamine 20 mcg/kg/min; phenylephrine 350 mcg/min
* Severe acidosis: potential of hydrogen (pH) below 7 in more than one arterial blood gas within 24 hours of ICU admission in the absence of diabetic ketoacidosis Surgical admission diagnosis
* Pregnancy
* Current prisoner

Primary outcomes:
measure: Number of Participants Who Had Hemoglobin Less Than 7 g/dL or Red Blood Cell (RBC) Transfusion Order
timeFrame: from time of admission to intensive care unit (ICU) to 30 days after admission to ICU
Secondary outcomes:
measure: Rate of Change in Hemoglobin (g/dL/Day) While in the Intensive Care Unit (ICU)
timeFrame: from time of randomization to completion of study (up to 30 days after ICU admission)
measure: Number of Participants Who Received a Red Blood Cell (RBC) Transfusion While in the ICU
timeFrame: completion of study (up to 30 days after ICU admission)
measure: Number of Participants With at Least One Inadequate Blood Sample for Laboratory Analysis
timeFrame: completion of study (up to 30 days after ICU admission)
measure: ICU Mortality
timeFrame: completion of study (up to 30 days after ICU admission)
measure: Total Phlebotomy Volume
timeFrame: completion of study (up to 30 days after ICU admission)
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Javier Barreda Garcia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barreda Garcia J, Xian JZ, Pedroza C, Salahuddin M, Mak G, Keene A, Cherian SV, Young AY, Vijhani P, Doshi PB. Pediatric size phlebotomy tubes and transfusions in adult critically ill patients: a pilot randomized controlled trial. Pilot Feasibility Stud. 2020 Aug 8;6:112. doi: 10.1186/s40814-020-00657-3. eCollection 2020.