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CompletedNCT03286465Updated Aug 30, 2021Results posted

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

An interventional study of Pediatric phlebotomy tubes and Adult phlebotomy tubes in Anemia, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-30.

Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Anemia

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Keywords

  • blood transfusion
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    Pediatric phlebotomy tubes

    Use of pediatric size tubes for diagnostic blood collection.

    Device: Pediatric phlebotomy tubes

  • Active comparator
    Adult phlebotomy tubes

    Use of adult size tubes for diagnostic blood collection.

    Device: Adult phlebotomy tubes

Interventions

  • DevicePediatric phlebotomy tubes

    Use of pediatric size tubes for diagnostic blood collection.

  • DeviceAdult phlebotomy tubes

    Use of adult size tubes for diagnostic blood collection.

05

What researchers measure

Primary outcomes

  1. Number of Participants Who Had Hemoglobin Less Than 7 g/dL or Red Blood Cell (RBC) Transfusion Order

    Time frame: from time of admission to intensive care unit (ICU) to 30 days after admission to ICU

Secondary outcomes

  1. 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).

    Time frame: from time of randomization to completion of study (up to 30 days after ICU admission)

  2. Number of Participants Who Received a Red Blood Cell (RBC) Transfusion While in the ICU

    Time frame: completion of study (up to 30 days after ICU admission)

  3. 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.

    Time frame: completion of study (up to 30 days after ICU admission)

  4. ICU Mortality

    Time frame: completion of study (up to 30 days after ICU admission)

  5. 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.

    Time frame: completion of study (up to 30 days after ICU admission)

06

Results

Posted Aug 30, 2021

Participant flow

Participant flow — Overall Study
MilestonePediatric Phlebotomy TubesAdult Phlebotomy Tubes
Started100100
Completed100100
Not completed00

Outcome measures

PrimaryNumber of Participants Who Had Hemoglobin Less Than 7 g/dL or Red Blood Cell (RBC) Transfusion Order
Time frame:
from time of admission to intensive care unit (ICU) to 30 days after admission to ICU
Reported as:
Count of participants · Participants
Number of Participants Who Had Hemoglobin Less Than 7 g/dL or Red Blood Cell (RBC) Transfusion Order
ParticipantsPediatric Phlebotomy TubesAdult Phlebotomy Tubes
Number of Participants Who Had Hemoglobin Less Than 7 g/dL or Red Blood Cell (RBC) Transfusion Order611
SecondaryRate 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).

Time frame:
from time of randomization to completion of study (up to 30 days after ICU admission)
Reported as:
Median · g/dL/day
Rate of Change in Hemoglobin (g/dL/Day) While in the Intensive Care Unit (ICU)
g/dL/dayPediatric Phlebotomy TubesAdult Phlebotomy Tubes
Rate of Change in Hemoglobin (g/dL/Day) While in the Intensive Care Unit (ICU)-0.21 (-0.48 to 0.021)-0.2 (-0.54 to 0.038)
SecondaryNumber of Participants Who Received a Red Blood Cell (RBC) Transfusion While in the ICU
Time frame:
completion of study (up to 30 days after ICU admission)
Reported as:
Count of participants · Participants
Number of Participants Who Received a Red Blood Cell (RBC) Transfusion While in the ICU
ParticipantsPediatric Phlebotomy TubesAdult Phlebotomy Tubes
Number of Participants Who Received a Red Blood Cell (RBC) Transfusion While in the ICU49
SecondaryNumber 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.

Time frame:
completion of study (up to 30 days after ICU admission)
Reported as:
Count of participants · Participants
Number of Participants With at Least One Inadequate Blood Sample for Laboratory Analysis
ParticipantsPediatric Phlebotomy TubesAdult Phlebotomy Tubes
Number of Participants With at Least One Inadequate Blood Sample for Laboratory Analysis7—
SecondaryICU Mortality
Time frame:
completion of study (up to 30 days after ICU admission)
Reported as:
Count of participants · Participants
ICU Mortality
ParticipantsPediatric Phlebotomy TubesAdult Phlebotomy Tubes
ICU Mortality910
SecondaryTotal 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.

Time frame:
completion of study (up to 30 days after ICU admission)
Reported as:
Median · mL
Total Phlebotomy Volume
mLPediatric Phlebotomy TubesAdult Phlebotomy Tubes
Total Phlebotomy Volume21 (7 to 38)50 (27 to 100)

Adverse events

Collected over time of randomization to completion of study (up to 30 days after ICU admission). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Pediatric Phlebotomy Tubes9/100 (9%)9/100 (9%)0/100 (0%)
Adult Phlebotomy Tubes10/100 (10%)10/100 (10%)0/100 (0%)
Most frequent serious events
Most frequent serious events
EventPediatric Phlebotomy TubesAdult Phlebotomy Tubes
deathGeneral disorders9/10010/100

Baseline characteristics

Age, Continuous
Age, Continuous(years)Pediatric Phlebotomy TubesAdult Phlebotomy TubesTotal
Mean55 ± 16.757 ± 18.556.2 ± 17.9
Sex: Female, Male
Sex: Female, Male(Participants)Pediatric Phlebotomy TubesAdult Phlebotomy TubesTotal
Female455196
Male5549104
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Pediatric Phlebotomy TubesAdult Phlebotomy TubesTotal
Black364682
White383977
Other261541
Region of Enrollment
Region of Enrollment(Participants)Pediatric Phlebotomy TubesAdult Phlebotomy TubesTotal
United States100100200
Hemoglobin concentration at intensive care unit (ICU) admission
Hemoglobin concentration at intensive care unit (ICU) admission(g/dL)Pediatric Phlebotomy TubesAdult Phlebotomy TubesTotal
Mean11.4 ± 2.411.1 ± 2.311.24 ± 2.35
Time from ICU admission to randomization
Time from ICU admission to randomization(hours)Pediatric Phlebotomy TubesAdult Phlebotomy TubesTotal
Median5.3 (1.5 to 8)5.7 (2.6 to 8.6)5.64 (2.15 to 8.47)
Estimated blood volume
Estimated blood volume(liters)Pediatric Phlebotomy TubesAdult Phlebotomy TubesTotal
Median4.9 (4.2 to 5.6)4.6 (3.9 to 5.4)4.77 (3.97 to 5.51)
Number of participants with chronic hemodialysis
Number of participants with chronic hemodialysis(Participants)Pediatric Phlebotomy TubesAdult Phlebotomy TubesTotal
Count of participants121224

7 further baseline measures are reported on the registry.

07

Study locations

1 site
  • Memorial Hermann Hospital
    Houston, Texas 77030, United States
08

References and documents

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. PubMed 32782818 ↗

Study documents

  • Protocol and statistical analysis plan · Sep 28, 2017

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03286465
Lead sponsor
The University of Texas Health Science Center, Houston
Responsible party
Javier Barreda Garcia (Assistant Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Sep 18, 2017
Start date
Nov 7, 2017
Primary completion
Sep 30, 2018
Completion
Sep 30, 2018
Results posted
Aug 30, 2021
Last update
Aug 30, 2021

Study contacts

Javier Barreda Garcia, MD
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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