Use of Pediatric Size Phlebotomy Tubes in Adult Critically Ill Patients to Reduce Red Blood Cell Transfusions

Pilot, Randomized Trial of the Use of Pediatric Size Phlebotomy Tubes in Adult Critically Ill Patients to Reduce Red Blood Cell Transfusions

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.

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Device: Pediatric phlebotomy tubes; Device: Adult phlebotomy tubes

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Memorial Hermann Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pediatric phlebotomy tubes; Use of pediatric size tubes for diagnostic blood collection.	Device: Pediatric phlebotomy tubes; Use of pediatric size tubes for diagnostic blood collection.
ACTIVE_COMPARATOR: Adult phlebotomy tubes; Use of adult size tubes for diagnostic blood collection.	Device: Adult phlebotomy tubes; Use of adult size tubes for diagnostic blood collection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants Who Had Hemoglobin Less Than 7 g/dL or Red Blood Cell (RBC) Transfusion Order	from time of admission to intensive care unit (ICU) to 30 days after admission to ICU

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Change in Hemoglobin (g/dL/Day) While in the Intensive Care Unit (ICU)	This will be calculated as the most recent hemoglobin prior to randomization minus the last hemoglobin prior to ICU discharge, death, RBC transfusion, clinical bleeding, surgery, or change of clinical status to comfort measures, divided by the number of days (rounded to the nearest 0.5) between these two values (crude estimate).	from time of randomization to completion of study (up to 30 days after ICU admission)
Number of Participants Who Received a Red Blood Cell (RBC) Transfusion While in the ICU		completion of study (up to 30 days after ICU admission)
Number of Participants With at Least One Inadequate Blood Sample for Laboratory Analysis	An inadequate blood sample is defined as any blood sample that requires recollection.	completion of study (up to 30 days after ICU admission)
ICU Mortality		completion of study (up to 30 days after ICU admission)
Total Phlebotomy Volume	The total phlebotomy volume is the total volume of blood collected over all days and is estimated based on the maximum volume needed for each type of blood test, as follows. In the pediatric tube arm, the volumes were 0.5 milliliters (mL) for hematology, 0.6 mL for chemistries (plasma), and 2.5 mL for coagulation tests. In the adult tube group, the volumes were 5.5 mL for hematology, 5 mL for chemistries (plasma), and 3.8 mL for coagulation. In both arms, tube volumes for lactate, immunology (serum), arterial blood gases, and blood cultures were 5 mL, 6.5 mL, 1 mL, and 10 mL, respectively.	completion of study (up to 30 days after ICU admission)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 7, 2017
• Primary Completion (ACTUAL): September 30, 2018
• Study Completion (ACTUAL): September 30, 2018

Study Registration Dates

• First Submitted: September 14, 2017
• First Submitted That Met QC Criteria: September 15, 2017
• First Posted (ACTUAL): September 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: blood transfusion
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: HSC-MS-17-0280

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No