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Completed

NCT Number: NCT03286465

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pediatric phlebotomy tubes

Device

Use of pediatric size tubes for diagnostic blood collection.

Adult phlebotomy tubes

Device

Use of adult size tubes for diagnostic blood collection.

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)

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

    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).

  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

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

    An inadequate blood sample is defined as any blood sample that requires recollection.

  4. ICU Mortality

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

  5. Total Phlebotomy Volume

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

    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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 18, 2017
Registry last updated
Aug 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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